Identity
- Trade Name
- MicroFrance® FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- SIZER MCOR65 OSSICULOPLASTY 6.5MM FDA UDI
- Model / Reference
- MCOR65 FDA UDI
- Description
- SIZER MCOR65 OSSICULOPLASTY 6.5MM FDA UDI
Identifiers
- Catalog Number
- MCOR65 FDA UDI
- Primary DI / UDI-DI
- 10381780111245 FDA UDI
- FDA Product Code
- JYZ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical depth gauge, reusable
A comprehensive medical device designed to measure the depth of holes in bone during surgical procedures, providing accurate and reliable results for surgeons.
Similar devices
Also classified as Surgical depth gauge, reusable.
- Depth Gauge — I.T.S. GmbH · Class I
- FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
- FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
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
- Integra Microfrance
Sources (1)
- FDA UDI 69a69dfa-850b-444a-a5b8-815b207f538a 35 fields · synced Jun 27, 2026