Identity
- Trade Name
- BURR GUIDE 3 LEG 18X16 FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Model / Reference
- 18309 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012484053 FDA UDI
- 510(k) Number
- K072298 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, single-use 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
Yes
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
Yes
FDA UDI
Category: Surgical drill guide, single-use
Burr Guide 3 Leg 18x16 by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K072298 also covers:
- BURR GUIDE 3 LEG 10X8 — BIOPRO, INC.
- BURR GUIDE 3 LEG 14X12 — BIOPRO, INC.
- BURR GUIDE 4 LEG 10X8 — BIOPRO, INC.
- BURR GUIDE 4 LEG 18X16 — BIOPRO, INC.
- Burr Cutter — BIOPRO, INC.
- Burr Guide 3 Leg 10x8 — BIOPRO, INC.
- Burr Guide 3 Leg 14x12 — BIOPRO, INC.
- Burr Guide 3 Leg 18x16 — BIOPRO, INC.
- Burr Guide 4 Leg 10x8 — BIOPRO, INC.
- Burr Guide 4 Leg 14x12 — BIOPRO, INC.
- Burr Guide 4 Leg 18x16 — BIOPRO, INC.
- CLOVER STAPLE 3LEG COMPLETE KIT — 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 a9bf64ab-66c2-446b-82a0-b8f991d2d84e 33 fields · synced May 30, 2026