Identity
- Trade Name
- Sure-Cord Knitted Retraction Cord EUDAMEDSure-endo FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- Retraction Cord, Non-Impregnated EUDAMEDSure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #1, 100 in (254cm) FDA UDI
- Model / Reference
- SC-1 EUDAMEDFDA UDI
- Description
- Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #1, 100 in (254cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809264299562 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429SC2P EUDAMED
- Direct Marketing DI
- 08809264299562 EUDAMED
- FDA Product Code
- EIF FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sure-Cord Knitted Retraction Cord by Sure Dent Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926429SC2P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b525f02c-16e9-4470-a90d-cc44a46f1822 61 fields · synced Jul 9, 2026
- FDA UDI 9e9a4914-8c05-4697-b9dd-56eee49335cb 34 fields · synced May 30, 2026