Identity
- Trade Name
- Lone Star FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDI
- Device Name
- Lone Star Elastic Stays - 7 mm 2 finger Elastic stays FDA UDI
- Model / Reference
- 3327-4G FDA UDI
- Description
- Lone Star Elastic Stays - 7 mm 2 finger Elastic stays FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015546 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Tip Bend Radius — 7 Millimeter FDA UDI
Category: Surgical retractor/retraction system blade, single-use
Lone Star by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI a102e6b3-34ff-40da-bab1-fcc6f885551f 34 fields · synced Jun 9, 2026