Identity
- Trade Name
- Lone Star® EUDAMEDLone Star FDA UDILone Star® IRI Delivery FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDIInfrared tissue coagulation system FDA UDI
- Device Name
- Lone Star Scroto-Pak™ EUDAMEDLone Star Elastic Stays - 5 mm Elastic stays, Blunt FDA UDILone Star® IRI Delivery Tube Replacement FDA UDI
- Model / Reference
- 3316-8G EUDAMEDFDA UDI3611 EUDAMEDIRI-DTD FDA UDI
- Description
- Lone Star Elastic Stays - 5 mm Elastic stays, Blunt FDA UDILone Star® IRI Delivery Tube Replacement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015522 EUDAMEDFDA UDI00888937018240 FDA UDI
- Basic UDI-DI
- 0888937TD0692A EUDAMED
- FDA Product Code
- GAD FDA UDIKOA FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, single-use FDA UDIInfrared tissue coagulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI876.4730 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIFDA UDI
Single Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Tip Bend Radius — 5 Millimeter 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
Similar devices
Also classified as Surgical retractor/retraction system blade, single-use.
- AUTOMOTIVE KIT DIN13164-2022 in 2 PE bag — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- NEW DIN13169:2021 PLUS in GKB304 orange ABS box with two colors print, size: 38.5x27.2x13.8cm — Gauke Healthcare Co., Ltd · Class I
- First aid kits — Gauke Healthcare Co., Ltd · Class I
- BE COMBIKIT BLACK (Gdh+Vest+verbandset) — Hubei V-Medical Products Co.,Ltd. · Class I
- VERBANDDOOS LEGAAL JODIMA-ref 10.0046 compleet — Hubei V-Medical Products Co.,Ltd. · Class I
- Combi-bag PLUS FILLING, Shrink Foil pack-C3-2050 — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- PHARMACAR RED BAG — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- Coil Pack - Essentials — Clonallon Laboratories Ltd · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (3)
- FDA UDI d946d7e5-6369-454d-843e-51569f7a3957 34 fields · synced Sep 18, 2026
- FDA UDI ee90e09d-0a19-4b6b-95bf-c5c9313d4b25 34 fields · synced May 30, 2026
- EUDAMED f2135823-1082-4684-b873-3cfd78bf8e0a 61 fields · synced Sep 18, 2026