FDA Registration
Active
🇺🇸 United States
50mm Drill Bit
Reg #: 1828288
·
FEI: 1828288
·
Expires 2025
Products
1
Proprietary Names
250
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORCHID UNIQUE
- Registration Number
- 1828288
- FEI Number
- 1828288
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6688 Dixie Hwy
- City
- Bridgeport
- State
- MI
- ZIP
- 48722
- Country
- US
Owner / Operator
- Firm Name
- Unique Instruments Inc.
- Operator Number
- 10042005
- Address
- 6688 Dixie Hwy
- City
- Bridgeport
- State
- MI
- Postal Code
- 48722
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-10-04 |
Proprietary Names
50mm Drill Bit
E208823
BKS TriMax
35mm Drill Bit
EXTREMITY DRILL BIT P/N 118-02034
EXTREMITY DRILL BIT P/N 127-00027
25mm Drill Bit
EXTREMITY DRILL BIT P/N 102-00002
DRL, Q.C.2-FL,1.9MM
EXTREMITY DRILL BIT P/N 101-00013
DRL,Q.C.,2FL,BRAD PT,2.9MM
J-Latch Drill Bit 905-1027
DRL, STEP, CANN, QC, 3MM X 85MM
J-Latch Drill Bit 905-1007
DRL, QC, 2-FL, 5MM, POST
DRL,2FLT,3.2MM WZ-1-5150 SIGNAL MEDICAL
Extremity DRL,QC,CANN,3FL,4.5MM,PAINT (Rev C-01)
J-Latch Drill Bit 905-1011
DRL,Q.C. CANNULATED 4-FL,2.5MM
EXTREMITY DRILL BIT P/N 118-00027
J-Latch Drill Bit 905-1031
DRL,Q.C.,4MM DRILL CENTURION
DRL, 2-FL, QC, 2X452MM, GRAD, 17-4 # 705482
DRL,CHAM,4FL,1.6MM
J-Latch Drill Bit 905-1014
DRL,COUNTERSINK,CANN,2.7MM
EXTREMITY DRILL BIT P/N 118-02030
CSK, QC, CANN, 3MM
DRL,Q.C.,2FL,2.5MMX150MM(A3)
DRL,COUNTERSINK,CANN,3.5MM
DRL,Q.C., 2-FL,3.5MM 351174-0004S ORTHOFIX
BIT,DRILL APTIS MEDICAL
DRL,Q.C.,2FL,2.5MMX152MM(A3)
DRL,Q.C.2-FL,2.5MM
EXTREMITY DRILL BIT P/N 101-00011
DRL,Q.C., 2FL,BRAD PT, 2.7MM
DRL, TOOL, 2.3MM, 2-FL, C'SINK
DRL,Q.C.,4.5MM DRILL CENTURION
DRL, TIP, 4-FL, 16MM (182994-004)
DRL, TRI-FLAT, 2-FL, 4MM X 364MM
DRL, STEP, CANN, QC, 2.5MM X 105MM
DRL,QC WITH STOP,2-FL,4.4MM 11-80190-60
DRL,Q.C.,2-FL,2.5MMX12MM #98-1512
DRL, Q.C., 2-FL, 3 MM, REUSABLE
DRL, CANN, QC, 3-FL, 2.2MM X 90MM
DRL, QC, CANN, 2.5MM
EXTREMITY DRILL BIT P/N 101-00012
DRL,2 FLUTE,6 FLAT,15.75MM
J-Latch Drill Bit 905-1008
EXTREMITY DRILL BIT P/N 102-00018
DRL, 4FL, CANN, HALL, 4.3MM
DRL, Q.C., 2-FL, 3.3MM X 60MM
DRL, C-NOTCH, 2-FL, 2.4 MM
Integralife Bit,Drill QWIX®; I.CO.S®; HALLU®-FIX
DRL, STEP, CANN, QC, 3MM X 95MM
DRL,QC,2-FL,4.3MM
DRL,Q.C., 2-FL, 3.5MM, REUSABLE
DRL, Q.C., 2-FL, 4MM, REUSABLE
DRL, Q.C., 2-FL, 2.8 MM
DRL, Q.C., 2-FL, 4.2 MM X 286 MM
J-Latch Drill Bit 905=1034
DRL, 4-FL, 2 MM, CANN
DRL, Q.C., 2-FL, 3.3MM X 40MM
Extremity DRL,QC,2FL,3.5MM,PAINT,(REV.C-01)
DRL, 2 FLUTE, 6 FLAT, 21.25MM SZ 20 512520-022
J-Latch Drill Bit 905-1035
DRL, Q.C., 2-FL, 4MM X 25MM
Drill Bit W/QC 905-1001
DRL, Q.C., 2-FL, 4MMX60MM
DRL, 2 FLUTE, 6 FLAT, 6.75MM SZ 7 512520-008
DRL, QC, CANN, 2.2MM
DRL,Q.C.1.6MM,5MS,SMALL SCREW
DRL, STEP, CANN, QC, 2.5MM X 85MM
DRL,Q.C.,4-FL,2MM,CANN #AR-8610DB-30
CSK, QC, CANN, 3-3.5MM
DRL,Q.C.,3.5MM,5MS,CANN JONES DRI
DRL, QC, 2MM
DRL, 2-FL, QC, 2X452MM, GRAD, 1RK91 #705482-1RK
Integra QWIX®; I.CO.S®; HALLU®-FIX
DRL,Q.C.,CANNULATED,3-FL,2.7MM
J-Latch Drill Bit 905-1028
DRL, CONTRA, 3-FLUTE, .116DIA.
DRL,Q.C.,5MM DRILL CENTURION
DRL,Q.C.,2.5MM (20110592) ORTHOFIX
DRL,2 FLUTE, 6 FLAT, 10.75MM
DRL, Q.C., 3-FL, 2.5MM
DRL,Q.C.,2-FL,2.5MMX14MM #98-1514
DRL, STEP, CANN, QC, 2.5MM X 95MM
DRILL, Q.C., 2-FL, 1.3 MM
DRL,Q.C.,2-FL,2MM
DRL, 2 FLUTE, 6 FLAT, 13.75MM
DRL,Q.C.,CANNULATED,3-FL,1.9MM
DRL, J-NOTCH, 2-FL, 1.1 MM
DRL, QC, 2-FL, 2.5MM, COLLAR,MONO BLUE
DRL, Q.C., 2-FL, 2.8 MM, BRAD PT.
DRL, QC, 4-FL, 1.7 MM, CANN
DRL, QC, CANN, 3MM
DRL, STOP, Q.C., 2-FL
DRL, Q.C., 2-FL, 1.9 MM
DRL,Q.C.,2FL,2.5MMX154MM(A.O3)
DRL, CANN, 2 IN I (229237SND)
DRL, Q.C., 2-FL, 3.3MM X 25MM
DRL, Q.C., CANNULATED, 3-FL, 2.7MM
DRL, J-NOTCH, 2-FL, 1.8 MM
DRL, QC, CANN, 2MM
DRL,Q.C.,1.9MM,5MS,SMALL SCREW
DRL, QC, 3.5MM
DRL, CONTRA, 2-FL, 1.1 MM
DRL, AO, 2 IN I (159225 REV 04)
DRL,Q.C., 2FL,1.7MM
DRL, CANN, CHAMFER, 3-FL, 4.5MM
DRL, C-NOTCH, 2-FL, 0.7 MM
DRL, COUNTERSINK, CANN, 2.7MM
DRL,3 FLATS,2-FLUTE,3MM #C13720-01
DRL, CANN, HUDSON, 4-FL, 5.5MM
DRL, 2FL, KNURL, 3.2 MM X 117 MM
DRL, Q.C., 2-FL, 4MMX40MM
DRL, MINI QC, 2-FL, 2.4 MM
DRL, QC, 2.8MM
Extremity DRL,QC,2F,2.9MM,PAINT,(Rev.C-01)
DRL, COUNTERSINK, CANN, 3.5MM
J-Latch Drill Bit 905-1015
DRILL WITH AO CONNECTOR 2.5mmx125mm 905-1038
DRL, Q.C., 2-FL, 2 MM
BLD, 500-XXX, 12 TPI, .51", NO SET
DRL,Q.C.,4-FL,1.7MM,CANN #AR-8610DB-25
DRL, Q.C., 2-FL, 3.2 MM X 127 MM
DRL, 4-FL, CANN, 3.2MM
DRL,2 FLUTE,6 FLAT,17.75MM
DRL, QC, 2-FL, 2.5MM, COLLAR,CHR.YELLOW
Depuy Synthes Drill Bit Series 007, 010, 114, 119, 161, 501,
DRL, QC, 2-FL, 2.5MM, COLLAR, MAGENTA
DRL, Q.C., 2-FL, 4.2 MM X 178MM
DRL, J-NOTCH, 2-FL, 1.5 MM
DRL, Q.C., CANNULATED, 3-FL, 1.9MM
Depuy Synthes Drill Bit Series 495, 509, 310.68, 235.96, 335, 324, 356, 357, 360, 387, 388, 389, 513, SD310, SD315
DRL, 2-FL, 6.25MM, 6 FLAT
DRL, STEP, CANN, QC, 3MM X 105MM
DRL, Q.C. 2-FL, 1.7MM, REUSABLE
DRL, Q.C., CANN, 4-FL, 2.8 MM
Depuy Synthes Drill Bit Series 600, 613, 614
VLP MINI-MOD 2.4MM OVERDRILL AO QC
1.5MM PROVISIONAL FIXATION WIRE LONG
2MM DRILL SHORT W/AO QC
Depuy Syhthes Drill Bit Series SD357, U44-645
DRL, Q.C., 2-FL, 4.8 MM X 280 MM
VLP MINI-MOD 2MM OVERDRILL SHORT AO QC
DRL, SLT, 2-FL, 4MM X 30MM
1.5MM DRILL LONG WITH AO QC
1.8MM DRILL SHORT W/AO QC
3.3mm Trident Drill 7005-3315S300 7005-3325S300 7005-3340S300 7005-3360S300
03.130.100 1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 75MM 03.130.101 1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED
315.93S 3.2MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION
1.8MM PROVISIONAL FIXATION WIRE SHORT
1.5MM PROVISIONAL FIXATION WIRE SHORT
315.92 2.5MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION
1.8MM DRILL LONG W/AO QC
03.50108 1.5MM DRILL BIT STRYKER J-LATCH/10MM STOP/82MM
OVERDRILL FOR 2.7MM SCREWS W/AO QC
03.130.200 1.1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 70MM 03.130.201 1.1MM DRILL BIT STRYKER J-LATCH F THREADED
317.861S 1.8MM DRILL BIT MINI QC 80MM STERILE
OVERDRILL FOR 2.4MM SCREWS W/ AO QC
03.130.300 1.5MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 88MM 03.130.301 1.5MM DRILL BIT STRYKER J-LATCH F THREADED
1.8MM PROVISIONAL FIXATION WIRE LONG
03.501.614 2.2MM DRILL BIT W/14MM STOP AO QUICK COUPLING/135MM
AR-8717D-02 Drill Bit Calibrated 2mm
03.130.302 1.5MM DRILL BIT MQC FOR THREADED HOLE 74MM 03.130.310 2MM DRILL BIT K-WIRE ATTCHMT FOR GLIDING HOLE 71MM
033721 10mm Cannulated Drill
2MM DRILL LONG W/AO QC
VLP MINI-MOD 1.5MM DRILL LONG AO QC
03.130.211 1.5MM DRILL BIT STRYKER J-LATCH F GLIDING HOLE 57MM 03.130.212 1.5MM DRILL BIT MQC FOR GLIDING HOLE 48MM
317.871S 2.4MM DRILL BIT MINI QC 80MM STERILE
VLP MINI-MOD 1.5MM DRILL SHORT AO QC
316.446 1MM DRILL BIT/STRYKER J-LTCH WITH 4MM STOP/44.5MM
AR-4158-03 3mm Calibrated Drill Bit
03.50116 1.5MM DRILL BIT STRYKER J-LATCH/18MM STOP/82MM
OVERDRILL FOR 2MM SCREWS W/AO QC
VLP MINI-MOD 1.8MM DRILL LONG AO QC
03.50114 1.5MM DRILL BIT STRYKER J-LATCH/16MM STOP/82MM
03.50118 1.5MM DRILL BIT STRYKER J-LATCH/20MM STOP/88MM
03.501.620 2.2MM DRILL BIT W/20MM STOP AO QUICK COUPLING/135MM
SHORT 3.5MM BRAD PT DRILL
033722 6MM / 9MM Cannulated Stepped Drill
316.451 Drill Bit ø1 w/Stop L44.5/4 2flute
AR-8717D-03 Drill Bit Calibrated 2.6mm
AR-8717D-01 Drill Bit Calibrated 1.6mm
03.50110 1.5MM DRILL BIT STRYKER J-LATCH/12MM STOP/82MM
03.501.610 2.2MM DRILL BIT W/10MM STOP AO QUICK COUPLING/135MM
03.501.616 2.2MM DRILL BIT W/16MM STOP AO QUICK COUPLING/135MM
03.501.618 2.2MM DRILL BIT W/18MM STOP AO QUICK COUPLING/135MM
4MM SHORT DRILL
03.50112 1.5MM DRILL BIT STRYKER J-LATCH/14MM STOP/82MM
4mm Trident Drill 7005-4015S300 7005-4025S300 7005-4040S300 7005-4060S300
TWIST DRILL 6.4MM
6MM/9MM CANNULATED TFNA STEPPED DRILL BIT
3.5MM GRAD BRAD PT DRILL
DISPOSABLE DRILL BIT 1.7
03.13000 0.8MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE 64MM
03.130.202 1.1MM DRILL BIT MQC FOR THREADED HOLE 56MM 03.130.210 1.5MM DRILL BIT K-WIRE ATTCHMT FOR GLIDING HOLE 62MM
10MM CANNULATED TAPERED DRILL BIT
310.507 1.5MM DRILL BIT W DEPTH MARK MINI QC 96 MM
03.130.311 2MM DRILL BIT STRYKER J-LATCH F GLIDING HOLE 66MM 03.130.312 2MM DRILL BIT MQC FOR GLIDING HOLE 57MM
APG+ QC CENT BIT 48 52 56 RU
TWIST DRILL 4MM
4MM SHORT AO PILOT DRILL
TWIST DRILL 5.5MM
315.93 3.2MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION
315.92S 2.5MM THREE-FLUTED DRILL BIT QC 230MM 200MM CALIBRATION
316.494 0.8MM DRILL BIT STRYKER J-LATCH F/THREADED HOLE 56MM
310.161 1.5MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH 110MM 310.162 1.8MM DRILL BIT W/DEPTH MARK STRYKER J-LATCH 110MM
03.130.102 1MM DRILL BIT K-WIRE ATTCHMT FOR THREADED HOLE 75MM 03.130.110 1.3MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING
MPDP0020 2mm Drill
316.385 Drill Bit ø0.8 L40 16 2flute
316.452 Drill Bit ø1 w/Stop L44.5/6 2flute
03.130.111 1.3MM DRILL BIT STRYKER J-LATCH F/GLIDING HOLE 55MM 03.130.112 1.3MM DRILL BIT MQC FOR GLIDING HOLE 46MM
Cannulated Drill Bit 4.5mm
03.501.606 2.2MM DRILL BIT W/6MM STOP AO QUICK COUPLING/135MM
03.501.612 2.2MM DRILL BIT W/12MM STOP AO QUICK COUPLING/135MM
AR-4158-02 2.5mm Calibrated Drill BIt
316.453 Drill Bit ø1 w/Stop L44.5/8 2flute
316.448 Drill Bit ø1 w/Stop L44.5/8 2flute
03.501.608 2.2MM DRILL BIT W/8MM STOP AO QUICK COUPLING/135MM
TWIST DRILL - 4.5MM
TWIST DRILL 4.3MM
SOLUTION SYSTEM CEM PLUG DRILLS
APG+ QC PERIPH BIT
AR-4158-05 Tap
316.447 1MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MM
DRILL BIT 3.2MM QC
APG+ QC CENT BIT 40 44
TWIST DRILL 3.5MM
DRILL BIT {} LONG 3.5MM QC
APG+ QC PERIPH BIT RU
TWIST DRILL 3.2MM
APG+ QC CENT BIT 40 44 RU
4MM LONG AO PILOT DRILL
Drill hybrid tool
Cannulated Drill Bit 6mm
P99-100-4630 Drill, 4.6x300mm, Solid, Trocar Tip
Cannulated Drill Bit 5mm
EVOS
AR-8925DC 3.7 mm Drill Bit, Cannulated, AO, Single-Use
APG+ QC CENT BIT 48 52 56
Cannulated Drill Bit 4mm
drl, cortex, 2-step
AR-8925DC-RU 3.7 mm Drill Bit, Cannulated, AO, Reusable
drl, qc, 4-fl, 3/4.5 mm
drl, qc, 2-step, cann
C23164-01
C22856-01
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)