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ALEUTIAN® Interbody Systems 3201-90134

by VB Spine LLC EUDAMEDGUDID

Active European Union

Ref 3201-90134Model 08858251006211SV

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006211SV Basic UDI-DIDate30 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10888857057890 UDI-DIDate14 Feb 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
ALEUTIAN® Interbody Systems
Generic Name
Surgical retractor/retraction system blade, reusable
Device Name
Aleutian: Spreader
Model / Ref / Catalog
3201-90134, 08858251006211SV
Primary DI / UDI-DI
10888857057890
Basic UDI-DI
08858251006211SV
Direct Marketing DI
10888857057890
FDA Product Code
LXH
EMDN Code
L0915 Spreaders and retractors for orthopaedic surgery, reusable
GMDN Term
Surgical retractor/retraction system blade, reusable
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Height — 16 Millimeter

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Category: Orthopaedic prosthesis implantation positioning instrument, reusable

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Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No