FDA Registration
Active
🇺🇸 United States
LINDEMANN DRILL, SHORT 2.2MM
Reg #: 1833986
·
FEI: 1000139987
·
Expires 2025
Products
1
Proprietary Names
240
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRECISION EDGE SURGICAL PRODUCTS COMPANY
- Registration Number
- 1833986
- FEI Number
- 1000139987
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 415 W 12th Ave
- City
- Sault Sainte Marie
- State
- MI
- ZIP
- 49783
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032303
Owner / Operator
- Firm Name
- Precision Edge Surgical Products Company
- Operator Number
- 10042577
- Address
- 415 West 12th Avenue
- City
- Sault Sainte Marie
- State
- MI
- Postal Code
- 49783
- Country
- US
- Correspondent
- Angela Gorsuch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2012-12-26 |
Proprietary Names
LINDEMANN DRILL, SHORT 2.2MM
ROUND DIAMOND BUR, 5.5MM SHORT
FLUTED DRUM 7.5x7.9MM, X-LONG
DRILL BIT W/4MM STOP, SH 1.3MM
PREC. NEURO W/DIA COATED SHANK
RD COARSE DIA BUR LONG 4MM
TPD ROUTER SHORT (2.3X19MM)
7MM BARREL BUR LNG W/13MM STOP
6MM CORNERSTONE BUR
BORING TOOL 15.6MMX10.4MM
ROUND DIAMOND BUR COARSE 4mm
DRILL BIT W/8MM STOP,MED 2MM
RND DIAMOND BUR EXTD MED 4MM
LINDEMANN DRILL, MEDIUM 2.2MM
7mm XX COARSE RND DIAMD BUR,SL
FLUTED DRUM 7.5x7.9MM, LONG
RD XXCOARSE DIA BUR, LG 6MM
ROUND DIAMOND BUR (3mm)
2.5MM STRAIGHT ROUTER
ROUND DIAMOND BUR, LONG 6MM
6MM RD FLUT BUR, X-LONG CARB
WIRE PASS DRILL MED (1.1MM)
DRILL BIT W/6MM STOP,SHT 2MM
DRILL BIT W/6MM STOP,MED 1MM
0.5 MM ROUND FLUTED BUR
RD XXCOARSE DIA BUR, MED 5MM
7.5x7.9mm XX CRS DIAMD DRUM,SL
PEAR BUR LONG (6MM)
RND DIAMND BUR EXTD LONG 3MM
DRILL BIT W/4MM STOP,SHT 1.5MM
NEURO DIAMOND DRIL 4.5 X 5.3mm
ROUND DIAMOND BUR COARSE 6mm
FLUTED DRUM 4.7x7.9MM, LONG
ROUND DIAMOND BUR 2.5MM LONG
ROUND DIAMOND BUR (5mm)
1.8X2.4MM NEURO DMD DRILL, LNG
ROUND DIAMOND BUR 3.5MM MEDIUM
1.5 MM STRAIGHT ROUTER
DRILL BIT W/11.6MM STOP 1.7MM
DRILL BIT W/4MM STOP,MED 3.5MM
3X3.8MM DMD NEURO DRILL, LNG
RD XXCOARSE DIA BUR, LG 4MM
TAPERED DRILL, SHORT 2.3MM
1.5MM TAPERED ROUTER
FLUTED DRUM 10.5x10.7MM, MED
PREC NEURO DRILL W/COATD SHANK
ROUND DIAMOND BUR, LONG 3MM
5120-50-64 - INVERTED CONE
RND DIAMOND BUR EXTD MED 1MM
DRILL BIT W/6MM STOP,SHT 1MM
3MM TAPERED ROUTER
TAPERED DRILL MEDIUM(2.3MM)
FLUTED DRUM 6x7.9MM, MEDIUM
SIDE CUT DRUM 6.1x3.8MM, LONG
ROUND DIAMOND BUR (6mm)
7MM BARREL BUR LNG W/15MM STOP
ROUND DIAMOND BUR 4.5MM LONG
FLUTED DRUM 4.7x16.4MM, LONG
ROUND FLUTED BUR, X-LONG 9.1MM
RND DIAMND BUR EXTD LONG 1MM
9.1x7.9mm XX CRS DIAMD DRUM,SL
2MM ROUND FLUTED BUR, AGGR
RD COARSE DIA BUR LONG 6MM
DRILL BIT W/4MM STOP,SHT 1MM
FLUTED DRUM 12.3x10.7MM, XLONG
TAPERED DRILL, MEDIUM 2.3MM
9MM CORNERSTONE BUR
ROUND DIAMOND BUR, SHORT 2MM
FLUTED DRUM 7.5x7.9MM, MEDIUM
4mm RND DIAMOND BUR,X-COARSE
3.1x19.1mm STRAIGHT ROUTER SL
NEURO DIAMOND DRILL 3X3.8MM
DRILL BIT W/8MM STOP,MED 1.5MM
3MM STRAIGHT ROUTER
RND DIAMND BUR EXTD LONG 4MM
RDN DIA BUR COARSE 1.5MM
FLUTED DRUM 10.5x10.7MM, XLONG
ROUND DIAMOND BUR, MED 2MM
NEURO DIAMOND DRIL 4 X 5.1mm
RND DIAMOND BUR EXTD MED 3MM
.7mm ROUND DIAMOND BUR
SIDE CUTTING DRILL, SHRT 2.3MM
ROUND DIAMOND BUR, SHORT 7MM
2.5MM TAPERED ROUTER
DRILL BIT W/8MM STOP,SHT 2MM
ROUND DIAMOND BUR (4mm)
ROUND DIAMOND BUR 4.5MM MEDIUM
RND DIA BUR LNG XCOARSE 4MM
4mm XX COARSE RND DIAMD BUR,SL
7.5 mm ACORN BUR, SUPER LONG
0.7 MM ROUND FLUTED BUR
ROUND FLUTED BUR, X-LONG 7.6MM
RD COARSE DIA. BUR, MED 5MM
8mm ROUND FLUTED BUR, S-LONG
DRILL BIT W/6MM STOP,SHT 1.5MM
ROUND DIAMOND BUR, SHORT 6MM
4.5mm ROUND DIAMOND BUR
ROUND DIAMOND BUR, MED 1MM
BORING TOOL 9.5MMX10.4MM
ROUND DIAMOND BUR, SHORT 1MM
ROUND DIAMOND BUR, LONG 1MM
6 mm ACORN BUR, SUPER LONG
.5mm ROUND DIAMOND BUR
ROUND DIAMOND EXTRA CRSE 4.5MM
5160-10-60 W/3MM DIAM.
DRILL BIT W/6MM STOP,MED 1.5MM
DRILL BIT W/6MM STOP,MED 3.2MM
ROUND DIAMOND BUR, 1.5MM MED
ROUND DIAMOND EXTRA CRSE 5.5MM
5mm XX COARSE RND DIAMD BUR,SL
RND DIAMOND BUR EXTD MED 2MM
DRILL BIT W/4MM STOP,SHT 2MM
ROUND DIAMOND BUR (2.5mm)
ROUND DIAMOND BUR, 2.5MM SHORT
TPD ROUTER SHORT (2.3X22MM)
PEAR BUR SHORT (6MM)
FLUTED DRUM,LONG(4.7MMX7.9MM)
9mm ROUND FLUTED BUR, S-LONG
9.1x7.9mm FLUTED DRUM, S-LONG
DRILL BIT W/8MM STOP,SHT 1MM
RD XXCRS DIA BUR, EXT LG 4MM
10.mm ROUND FLUTED BUR, S-LONG
1.6MM LD MED, ZIM 5091-212
8MM DIA. CORNERSTONE BUR
ROUND DIAMOND BUR, MED 5MM
RD COARSE DIA. BUR, MED 6MM
3mm ROUND FLUTED BUR, S-LONG
4.7x7.9mm FLUTED DRUM, S-LONG
ROUND DIAMOND EXTRA CRSE 3.5MM
7MM CORNERSTONE BUR
9MM DIA. CORNERSTONE BUR
ROUND DIAMOND BUR, SHORT 5MM
RND DIAMND BUR EXTD LONG 2MM
EIUS SYSTEM BUR
RND FLUTED BUR EXTD LONG 1MM
5mm RND DIAMOND BUR,X-COARSE
DRILL BIT W/8MM STOP,SHT 1.5MM
ROUND DIAMOND BUR (2mm)
RD XXCOARSE DIA BUR, LG 5MM
ACORN BUR 6.1X8MM, X-LONG
8MM CORNERSTONE BUR
FLUTED DRUM 9.1x7.9MM, LONG
10MM DIA. CORNERSTONE BUR
DRILL BIT W/6MM STOP,MED 2.5MM
FLUTED DRUM 9.1x4.4MM, MEDIUM
WIRE PASS DRILL MED (2MM)
STRAIGHT ROUTER 3.1x19.1MM XLG
RD XXCRS DIA BUR, EXT LG 5MM
2.9X3.8MM NEURO DRILL, X-LONG
RD COARSE DIA BUR LONG 5MM
ROUND DIAMOND BUR COARSE 2MM
6mm ROUND FLUTED BUR, S-LONG
DMD NEURO DRILL(3X3.8MM) MED
STRAIGHT FLUTED BARREL BUR 3MM
4.5mm ROUND DIAMOND BUR,COARSE
ROUND DIAMOND BUR COARSE 3mm
ROUND DIAMOND BUR 5.5MM MEDIUM
BORING TOOL LONG 9.5MMX10.4MM
ROUND DIAMOND BUR (1mm)
ROUND DIAMOND BUR, LONG 7MM
FLUTED DRUM 6x7.9MM, LONG
PEAR BUR LONG (4MM)
ROUND DIAMOND BUR (1.5mm)
FLUTED DRUM 4.7x16.4MM, MEDIUM
6mm RND DIAMOND BUR,X-COARSE
RD COARSE DIA. BUR, MED 3MM
FLUTED DRUM 9.1x7.9MM, MEDIUM
SWNSN PILT PT BUR, 2MM SHORT
RND DIAMND BUR EXTD LONG 5MM
DRILL BIT W/4MM STOP,MED 1.5MM
2.2 mm LINDEMANN DRILL
MIS COARSE ROUND DIA BUR 3MM
5mm ROUND FLUTED BUR, S-LONG
ROUND DIAMOND BUR, SHORT 4MM
ROUND DIAMOND BUR, LONG 2MM
ROUND DIAMOND BUR 5.5MM LONG
6.5MM BARREL BUR,DIA,X-COURSE
2 MM STRAIGHT ROUTER
FLUTED DRUM 4.7x7.9MM, X-LONG
ROUND DIAMOND BUR 3.5MM LONG
RD COARSE DIA. BUR, MED 4MM
4MM CORNERSTONE BUR
DRILL BIT W/4MM STOP,MED 1MM
6mm XX COARSE RND DIAMD BUR,SL
FLUTED DRUM 9.1x7.9MM, X-LONG
TPD ROUTER 1.7mmX16mm
3MM TAPERED RND CRSE DIA ELITE
RND FLTED BUR, EXTRA LNG 5MM
DRILL TIP, MEDIUM 1.5MM
TAPERED ROUTER,LG 2.3MMX30MM
TPRD ROUTER EXLONG(2.3X22MM)
ROUND DIAMOND BUR COARSE 1MM
FLUTED DRUM 6x7.9MM, X-LONG
NEURO DIAMOND DRIL 3.5 X 4.3mm
RD XXCOARSE DIA BUR, MED 6MM
NEURO DIAMOND DRIL 2 X 3.1mm
NEURO DIAMOND DRIL 2.5 X 3.4mm
1.8X2.4MM NEURO DMD DRILL, MED
5MM CORNERSTONE BUR
RND FLUTED BUR, EXTD MED 1MM
ROUND FLUTED BUR, X-LONG 6MM
ROUND DIAMOND BUR, SHORT 3MM
FLUTED DRUM 9.1x4.4MM, LONG
5.5mm ROUND DIAMOND BUR,COARSE
ACORN BUR 9.1X11.4MM, X-LONG
ACORN BUR 7.5X9.5MM, X-LONG
RND DIA BUR LNG X/COARSE 5MM
6.4MM INVERTED CONE BUR, MED.
RD COARSE DIA BUR LONG 3MM
7MM DIA. CORNERSTONE BUR
SWNSN PILT PT BUR, 4MM SHORT
TPRD ROUTER EXLONG(2.3X3MM)
ROUND DIAMOND BUR, MED 6MM
STRAIGHT FLUTED BARREL BUR 4MM
RD COURSE DIA. BUR, SHT 4mm
5MM DIA. CORNERSTONE BUR
FLUTED DRUM 4.7x7.9MM, MEDIUM
ROUND DIAMOND BUR COARSE 5mm
FLUTED DRUM BUR(4.7MMX7.9MM)
DRILL BIT W/8MM STOP,MED 2.5MM
DRILL BIT W/6MM STOP,MED 2MM
ROUND DIAMOND BUR 2.5MM MEDIUM
BORING TOOL LONG 12.6MMX10.4MM
NEURO DIAMOND DRL CRSE 3X3.8MM
3.5mm ROUND DIAMOND BUR
3.5mm ROUND DIAMOND BUR,COARSE
7mm ROUND FLUTED BUR, S-LONG
5.5mm ROUND DIAMOND BUR
2MM TAPERED ROUTER
STRAIGHT FLUTED BARREL BUR 5MM
DRILL BIT W/8MM STOP,MED 1MM
FLUTED DRUM 10.5x10.7MM, LONG
ROUND DIAMOND BUR, MED 7MM
TPD ROUTER LONG (2.3X15.9MM)
FLUTED DRUM 7.6x28.6MM, LONG
9 mm ACORN BUR, SUPER LONG
NEURO DIAMOND DRIL 3 X 3.8mm
3MM DIA NEURO BUR, CRS, LONG
3mm RND DIAMND BUR, X-COARSE
RND DIAMOND BUR EX COARSE2.5MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)