Identity
- Trade Name
- KAT APPLANATION PRISM FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Model / Reference
- 2414-P-5001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055272716529 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, manual 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, manual
Kat Applanation Prism by Keeler Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, manual.
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- Sklar® — Sklar Corporation · Class II
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- SCHIOTZ TONOMETER — Katena Products, Inc. · Class II
- Applanation Tonometer — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
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
- Keeler Limited
Sources (1)
- FDA UDI fea773f2-237f-4974-8f37-c9c50d2f09d6 32 fields · synced May 30, 2026