Identity
- Trade Name
- WRIST STAPLE INSTRUMENT TRAY FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Model / Reference
- 19480 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012483995 FDA UDI
- 510(k) Number
- K072298 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Orthopaedic surgical procedure kit, non-medicated, reusable
Wrist Staple Instrument Tray by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
- Knee Instruments — Medacta International · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Spine Instruments — Medacta International · Class I
- Knee Instruments — Medacta International · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- General Instruments — ORTHOPEDIATRICS CORP. · Class I
- Hip Instruments — Medacta International · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
Cleared under the same submission
K072298 also covers:
- 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 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.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI ec9b61a9-a610-4be9-ae6e-8d97543f09bd 33 fields · synced Jun 1, 2026