Identity
- Trade Name
- uNion MAX FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- 8mm Trial drill guide, 6° L FDA UDI
- Model / Reference
- UU202-06-0008 FDA UDI
- Description
- 8mm Trial drill guide, 6° L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810076333809 FDA UDI
- 510(k) Number
- K240515 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
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 drill guide, reusable
uNion MAX by Ulrich Medical Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical drill guide, reusable.
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Cleared under the same submission
K240515 also covers:
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
- uNion MAX — ULRICH MEDICAL USA, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ulrich Medical Usa, Inc.
Sources (1)
- FDA UDI 4b0acc2f-fa84-4847-a692-7ca40f64499d 35 fields · synced May 31, 2026