Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- General-purpose surgical spatula FDA UDI
- Device Name
- Integra® Schuknecht Spatula, Round Tip FDA UDI
- Model / Reference
- 3722133 FDA UDI
- Description
- Integra® Schuknecht Spatula, Round Tip FDA UDI
Identifiers
- Catalog Number
- 3722133 FDA UDI
- Primary DI / UDI-DI
- 10381780082415 FDA UDI
- FDA Product Code
- GAF FDA UDI
- GMDN Term
- General-purpose surgical spatula 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
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
Dimensions & Sizes
- Size
- Width — 1 Millimeter FDA UDI
Category: General-purpose surgical spatula
Integra® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose surgical spatula.
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Sklar® — Sklar Corporation · Class I
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MicroFrance® — Integra Microfrance · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI dd73ed9d-025f-4ea1-939f-054601a8bd46 36 fields · synced Jun 9, 2026