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Byd Care FE2311

by BYD Precision Manufacture Co., Ltd. 2 variants

Listed FDA GUDID listing, no authorization on record

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 Number00850022724176 UDI-DI Date30 Oct 2020ListedStatusListed GUDID: 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  • Withdrawn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
00850022724176
510(k) Number
FDA Product Code
FXX
GMDN Term
Surgical/examination garment kit
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 25.77 Square inch

Related devices

Category: Surgical/examination garment kit

Cleared under the same submission (K200923)

Other devices from BYD Precision Manufacture Co., Ltd.

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