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Medline-Microtek Probe Covers

by Microtek Medical LLC 61 variants

Listed FDA GUDID listing, no authorization on record

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 Number10748426147127 UDI-DI Date22 Jan 2026ListedStatusListed GUDID: 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  • Withdrawn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
Medline-Microtek
Generic Name
Body-surface ultrasound imaging transducer cover
Model / Ref / Catalog
Probe Covers, 3827N
Primary DI / UDI-DI
10748426147127
FDA Product Code
PUI
GMDN Term
Body-surface ultrasound imaging transducer cover
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Microtek Medical LLC

See all devices from Microtek Medical LLC →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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