Skip to content

Lone Star 3329-4G

by CooperSurgical, Inc.

Ref 3329-4GModel 3611

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number0888937TD0692A Basic UDI-DI 00888937015553UDI-DIDate12 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number0888937TD0692A Basic UDI-DI 00888937015553UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888937015553 UDI-DI Date30 Oct 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Lone Star® EUDAMED
Lone Star GUDID
Generic Name
Surgical retractor/retraction system blade, single-use
Device Name
Lone Star Scroto-Pak™
Model / Reference
3329-4G, 3611
Primary DI / UDI-DI
00888937015553
Basic UDI-DI
0888937TD0692A, B-00888937015553
FDA Product Code
GAD
EMDN Code
V9012 Non-specialist surgical instruments and kits, single-use
GMDN Term
Surgical retractor/retraction system blade, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Tip Bend Radius — 9 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No