Identity
- Trade Name
- Scroto-Pak™ EUDAMEDLone Star FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDI
- Device Name
- Lone Star Scroto-Pak™ EUDAMEDSCROTO-PAK (3311 STAYS) FDA UDI
- Model / Reference
- 3611 EUDAMEDFDA UDI
- Description
- SCROTO-PAK (3311 STAYS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937017892 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD0692A 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
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
No
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
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 5e92ec81-543b-4f2a-8d9c-d89de3350e1e 33 fields · synced Jun 18, 2026
- EUDAMED ce60057f-8ea2-4a0d-a175-143b8c156b7f 61 fields · synced Jun 18, 2026