Identity
- Trade Name
- Lone Star™ EUDAMEDLone Star FDA UDI
- Generic Name
- Surgical retraction system, single-use FDA UDI
- Device Name
- Lone Star® Retractor System™ EUDAMEDSKW Deep Scrotal Retraction System FDA UDI
- Model / Reference
- 72403867 EUDAMEDFDA UDI3707 EUDAMED
- Description
- SKW Deep Scrotal Retraction System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937012400 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD007sYJ EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Surgical retraction system, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical retraction system, single-use
Lone Star by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, single-use.
- Medacta Broach Handle — UNIQUE SURGICAL, LLC · Class I
- evonos — Evonos GmbH & Co. KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI b0b8f853-37cd-4f1d-8f4d-cd698b0433e6 33 fields · synced Aug 2, 2026
- EUDAMED 3eb437e9-6199-48e0-a988-34a7c4ad81e2 61 fields · synced Aug 2, 2026