Identity
- Trade Name
- Lone Star FDA UDI
- Generic Name
- Surgical retraction system mounting frame, reusable FDA UDI
- Device Name
- Lone Star reusable retractor ring - small round FDA UDI
- Model / Reference
- 1103 FDA UDI
- Description
- Lone Star reusable retractor ring - small round FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015287 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retraction system mounting frame, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 11.6 Centimeter FDA UDIWeight — 96 Gram FDA UDI
Category: Surgical retraction system mounting frame, reusable
Lone Star by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system mounting frame, reusable.
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- Hayden Medical — Hayden Medical Inc · Class I
- Retractor, Spinal, ring-handle, Längs with hinge with catch — Geister Medizin Technik GmbH · Class II
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 710c9b7d-5f13-44c4-b8fe-3c4c3fc80939 34 fields · synced Jun 9, 2026