Identity
- Trade Name
- P-K Titanium Motility Peg System FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument. FDA UDI
- Model / Reference
- I00057 FDA UDI
- Description
- Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854066006236 FDA UDI
- FDA Product Code
- LRZ FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
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
P-K Titanium Motility Peg System by Integrated Orbital Implants, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Integrated Orbital Implants, Inc.
Sources (1)
- FDA UDI 965a677f-08ff-4cb4-a667-66c99cba9081 34 fields · synced May 30, 2026