FDA Registration
Active
🇺🇸 United States
STERITECH, INC.
Reg #: 2650143
·
FEI: 2648209
·
Expires 2026
Products
36
Proprietary Names
57
Establishment Types
1
Classifications
36
Registration Details
- Registration Name
- STERITECH, INC.
- Registration Number
- 2650143
- FEI Number
- 2648209
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SALINAS INDUS. PK., LOT 7,, RD. 701
- City
- SALINAS
- State
- PR
- ZIP
- 00751
- Country
- US
Owner / Operator
- Firm Name
- STERITECH, INC.
- Operator Number
- 2650143
- Address
- SALINAS INDUS. PK., LOT 7,, RD. 701
- City
- Salinas
- State
- PR
- Postal Code
- 00751
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2013-02-26 |
| Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | JOD | Class 2 | Cardiovascular | No | 2013-02-20 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-02-27 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2013-02-27 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2013-03-13 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2013-02-26 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-26 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-02-26 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2013-02-26 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-02-26 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-02-26 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2013-02-26 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2013-02-27 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2014-01-21 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2013-03-13 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-26 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2013-02-26 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2013-03-13 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2013-02-01 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2013-03-13 |
| Microfilter, Blood Transfusion | CAK | Class 2 | General Hospital | No | 2013-02-20 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 1992-12-17 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2013-02-27 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2013-02-26 |
| Regulator, Vacuum | KDP | Class 2 | General Hospital | No | 2013-02-26 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2013-02-26 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2013-02-27 |
| Material, Dressing, Surgical, Polylactic Acid | LPG | Class 3 | Unknown | No | 2013-03-13 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2013-03-13 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2013-03-13 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2013-02-26 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2013-03-13 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2013-02-26 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2024-03-04 |
| Stimulator, Invasive Bone Growth | LOE | Class 3 | Unknown | No | 2015-01-16 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-26 |
Proprietary Names
D186175
D185254
D186367
D186375
D187800
D186187
D186177
D186171
D186163
D186170
D186166
D186179
D186181
D186374
D186185
D211735
D187836
D186160
D186182
D186164
D187813
D187808
D181316
D186167
D187699
D187803
D186162
D185252
A462871
D186359
D186155
D186159
D186376
D187805
D186361
D186369
D186176
D187815
D187809
D186172
D187816
D187837
D186370
D187806
D186184
D187835
D186157
D530486
D186188
D234932
D186153
D186156
D187810
D186165
D234933
D186360
D187801
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)