← Back to catalogue

Lone Star

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Lone Star FDA UDI
Generic Name
Surgical retraction system mounting frame, single-use FDA UDI
Device Name
LoneStar Disposable Retractor Ring - 25 cm x 25 cm FDA UDI
Model / Reference
3310G FDA UDI
Description
LoneStar Disposable Retractor Ring - 25 cm x 25 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00888937015409 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Surgical retraction system mounting frame, 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
Outer Diameter — 25 Centimeter FDA UDI

Category: Surgical retraction system mounting frame, 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 retraction system mounting frame, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI a5bcc42d-4ddb-4b35-9a45-810acf471fbb 34 fields · synced Jun 9, 2026