Identity
- Trade Name
- Lone Star® Retractor System™ EUDAMEDLone Star FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDI
- Device Name
- Lone Star® Retractor System™ EUDAMEDLone Star Retractor System COLORECTAL KIT, BOX OF 5 FDA UDI
- Model / Reference
- 3707 EUDAMEDFDA UDI
- Description
- Lone Star Retractor System COLORECTAL KIT, BOX OF 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015430 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 retractor/retraction system blade, 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 25 Centimeter FDA UDI
Category: Surgical retractor/retraction system blade, single-use
Lone Star by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 07e1c5f7-cdde-49d4-91eb-d839144c4b0e 34 fields · synced Jul 9, 2026
- EUDAMED fa19cb98-9c68-44b1-80dd-cf782b4cd0c5 61 fields · synced Jul 9, 2026