Identity
- Trade Name
- Mastel Precision Surgical Instruments, Inc. FDA UDI
- Generic Name
- Ophthalmic knife, reusable FDA UDI
- Device Name
- Elite II Fine Stealth Triamond .3 Tip, Profile, Compass FDA UDI
- Model / Reference
- 12.323.2016 FDA UDI
- Description
- Elite II Fine Stealth Triamond .3 Tip, Profile, Compass FDA UDI
Identifiers
- Catalog Number
- 12.323.2016 FDA UDI
- Primary DI / UDI-DI
- 00642356120096 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mastel Precision Surgical Instruments, Inc. by Mastel Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Mastel Surgical Inc.
Sources (1)
- FDA UDI cae7f5eb-f370-4394-bb58-79f27406006e 36 fields · synced Jun 1, 2026