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Byd Care FE2311

by Global Healthcare Product Solutions, LLC 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850022724183 UDI-DI Date7 Mar 2021ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Byd Care
Generic Name
Surgical/examination garment kit
Model / Ref / Catalog
FE2311
Primary DI / UDI-DI
00850022724183
510(k) Number
FDA Product Code
FXX
GMDN Term
Surgical/examination garment kit
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution
Size
Area/Surface Area — 25.77 Square inch

Related devices

Cleared under the same submission (K200923)

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No