Identity
- Trade Name
- Hoffee Suture Retriever FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Intended to aid in the passing of sutures through bone and soft tissue during orthopedic surgery FDA UDI
- Model / Reference
- 710000NS FDA UDI
- Description
- Intended to aid in the passing of sutures through bone and soft tissue during orthopedic surgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840113230525 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suturing unit, single-use
Hoffee Suture Retriever by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, single-use.
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- SlingShot — Stryker Corp. · Class I
- NanoPass — Stryker Corp. · Class I
- DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · Class I
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
- Aspen Surgical Products, Inc.
Sources (1)
- FDA UDI d3f5a821-1e2b-45f9-af76-5788049a30f4 34 fields · synced Jun 9, 2026