Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Stainless steel 3 inch (7.62 cm) by 0.5 inch (1.27 cm) “T” handle, overall 9 inch (22.86 cm) length, distal end 1/4 inch (6.35mm) counter sunk 0.5 inch (1.27 cm) hex ratchet with a rounded 2mm stainless pin protruding 2mm past the end of the ratchet. FDA UDI
- Model / Reference
- 335250-396 FDA UDI
- Description
- Stainless steel 3 inch (7.62 cm) by 0.5 inch (1.27 cm) “T” handle, overall 9 inch (22.86 cm) length, distal end 1/4 inch (6.35mm) counter sunk 0.5 inch (1.27 cm) hex ratchet with a rounded 2mm stainless pin protruding 2mm past the end of the ratchet. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G4533352503960 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Peak Medical by PEAK MEDICAL Distribution Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PEAK MEDICAL Distribution Inc
Sources (1)
- FDA UDI 3ef1dc09-c5eb-4b5c-b37b-9641d6b63a4c 33 fields · synced Jun 6, 2026