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Subcutaneous Guidewire - Medium 41.240.502

by Arkis Biosciences Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10866614000181 UDI-DI Date14 Dec 2018ListedStatusListed 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  • Withdrawn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
Subcutaneous Guidewire - Medium
Generic Name
Subcutaneous tunneller, single-use
Model / Ref / Catalog
41.240.502
Primary DI / UDI-DI
10866614000181
FDA Product Code
MDM, HAO, GYK
GMDN Term
Subcutaneous tunneller, single-use
Device Class
Class I
Regulation Number
878.4800, 882.4535, 882.4545
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Arkis Biosciences Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No