Identity
- Trade Name
- FMAT1 Prism B FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Device Name
- Disposable single use prism for FMAT1 Device FDA UDI
- Model / Reference
- Prism B FDA UDI
- Description
- Disposable single use prism for FMAT1 Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867009000215 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer tip cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Liquid Chemical FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Centimeter FDA UDI
Category: Ophthalmic tonometer tip cover
FMAT1 Prism B by Falck Medical, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Falck Medical, Inc.
Sources (1)
- FDA UDI a928615e-55c4-4146-9cab-e1fc95a18d80 35 fields · synced Jun 8, 2026