Identity
- Trade Name
- Drill Guide 7 - 9MM FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Model / Reference
- 17648 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209176480 FDA UDI
- 510(k) Number
- K061798 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, reusable
Drill Guide 7 - 9MM by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
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- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Cleared under the same submission
K061798 also covers:
- 12mm STEP STAPLE 15X20-2X2 — BIOPRO, INC.
- 9mm STEP STAPLE 15X20-2X2 — BIOPRO, INC.
- ANCHOR PIN — BIOPRO, INC.
- ANGLED STAPLE PUNCH — BIOPRO, INC.
- Anchor Pin — BIOPRO, INC.
- BIOPRO MEMORY STAPLE 13X15-1.5X1.5MM PKG — BIOPRO, INC.
- DRILL GUIDE 15 18MM — BIOPRO, INC.
- DRILL GUIDE 7 9MM — BIOPRO, INC.
- DRILL GUIDE ADJUSTABLE — BIOPRO, INC.
- Drill Guide Single Hole — BIOPRO, INC.
- LARGE STAPLE 30x30 — BIOPRO, INC.
- LARGE STAPLE CLAMP — BIOPRO, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 98854870-3aff-4fce-bddc-7f2e0bbbcbce 33 fields · synced May 29, 2026