Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Corneoscleral punch FDA UDI
- Device Name
- Descemet's Punch EUDAMEDFDA UDI
- Model / Reference
- 7-105 EUDAMEDFDA UDI
- Description
- Descemet's Punch FDA UDI
Identifiers
- Catalog Number
- 7-105 FDA UDI
- Primary DI / UDI-DI
- 05055313811350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313811350 EUDAMED
- FDA Product Code
- HMZ FDA UDI
- EMDN Code
- L170499 OPHTHALMOLOGY SHARP INSTRUMENTS (EXCLUDING SCISSORS), REUSABLE - OTHER EUDAMED
- GMDN Term
- Corneoscleral punch FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
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
Descemet's Punch by Duckworth & Kent Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05055313811350 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Duckworth & Kent Ltd.
- EUDAMED SRN
- GB-MF-000002176
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 495ab6e3-7a98-4ab5-83c2-b2b83f5eddd0 61 fields · synced Jul 9, 2026
- FDA UDI c9a2b141-30e2-42df-9b71-6fd840687e45 36 fields · synced May 30, 2026