Identity
- Trade Name
- EKCOMED FDA UDI
- Generic Name
- Suture knot pusher, single-use FDA UDI
- Device Name
- SUREtriever Suture Retriever FDA UDI
- Model / Reference
- EKM-SR10B FDA UDI
- Description
- SUREtriever Suture Retriever FDA UDI
Identifiers
- Catalog Number
- EKM-SR10B FDA UDI
- Primary DI / UDI-DI
- 00850000965010 FDA UDI
- FDA Product Code
- HTD FDA UDI
- GMDN Term
- Suture knot pusher, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Suture knot pusher, single-use
SUREtriever Suture Retriever is a hand-held, single-use manual surgical instrument designed to facilitate internal suturing procedures. This device enables users to advance suture knots extracorporeally and apply appropriate tension, ensuring secure and effective closure.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ekcomed Inc.
Sources (1)
- FDA UDI 70fa213f-cd55-461a-b955-857251b1359a 35 fields · synced Jul 11, 2026