Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Half Ring Glenoid Drill Guide, 5.75" (14.6cm) overall length. 3" (7.62 cm) x 6.5mm threaded top handle. 2.75 (7cm) bottom handle 13.5mm bottom handle. Half ring female threaded sizing top. FDA UDI
- Model / Reference
- 33-23-21055BC FDA UDI
- Description
- Half Ring Glenoid Drill Guide, 5.75" (14.6cm) overall length. 3" (7.62 cm) x 6.5mm threaded top handle. 2.75 (7cm) bottom handle 13.5mm bottom handle. Half ring female threaded sizing top. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G453332321055BC0 FDA UDI
- FDA Product Code
- LXI FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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 drill guide, reusable
Peak Medical by PEAK MEDICAL Distribution 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
- PEAK MEDICAL Distribution Inc
Sources (1)
- FDA UDI e5ef7a72-f00f-4458-88f7-d8e60ad47166 33 fields · synced Jun 8, 2026