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Isobar 12VDP80-40

by Scient'X

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03661380009402 UDI-DI Date10 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Isobar
Generic Name
Bone-screw internal spinal fixation system, sterile
Model / Reference
12VDP80-40
Primary DI / UDI-DI
03661380009402
FDA Product Code
KWP, KWQ, MNI, MNH
GMDN Term
Bone-screw internal spinal fixation system, sterile
Device Class
Class II
Regulation Number
888.3050, 888.3060, 888.3070
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 40 Millimeter
Outer Diameter — 8 Millimeter

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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