Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Razor blade breaker/holder FDA UDI
- Device Name
- Integra® Miltex® Castroviejo Blade Breaker and Holder, 5-3/8", 12mm Smooth Jaws, Round Handle, With Lock FDA UDI
- Model / Reference
- 18-171 FDA UDI
- Description
- Integra® Miltex® Castroviejo Blade Breaker and Holder, 5-3/8", 12mm Smooth Jaws, Round Handle, With Lock FDA UDI
Identifiers
- Catalog Number
- 18-171 FDA UDI
- Primary DI / UDI-DI
- 10381780362517 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Razor blade breaker/holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDI
Category: Razor blade breaker/holder
Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 LifeSciences Production Corporation
Sources (1)
- FDA UDI 0cb44e7c-b27a-4d24-b7cc-dc1c96d02ec5 36 fields · synced Jun 9, 2026