Identity
- Trade Name
- Duckworth & Kent FDA UDI
- Generic Name
- Scleral marker, reusable FDA UDI
- Device Name
- Incision Marker EUDAMEDFDA UDI
- Model / Reference
- 9-846 EUDAMEDFDA UDI
- Description
- Incision Marker FDA UDI
Identifiers
- Catalog Number
- 9-846 FDA UDI
- Primary DI / UDI-DI
- 05055313824961 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055313824961 EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- L1715 SCLERAL MARKERS, REUSABLE EUDAMED
- GMDN Term
- Scleral marker, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4570 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- 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
Incision Marker 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-05055313824961 | 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 a178326e-a436-4dbe-be74-c3ab71f866e5 61 fields · synced Jul 21, 2026
- FDA UDI c5a5cab1-57bb-4f70-9355-5fd5ebb63518 35 fields · synced May 30, 2026