Identity
- Trade Name
- DEPTH GAUGE FDA UDI
- Generic Name
- Surgical depth gauge, single-use FDA UDI
- Model / Reference
- 18378 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012484114 FDA UDI
- 510(k) Number
- K072298 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical depth gauge, single-use 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: Surgical depth gauge, single-use
Depth Gauge by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, single-use.
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
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- FuzeFix Large — FUSION ORTHOPEDICS, LLC · Class I
- Solanas — ALPHATEC SPINE, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · 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 |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 8c2c4c3c-ae17-4794-8459-bd4741691950 33 fields · synced May 30, 2026