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3A Medical S4001

by 3A Medical Products Co., Ltd United States GUDID

Product code FYA

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850029191056 UDI-DIDate9 Mar 2021ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

GUDID · synced 22 Oct 2026

Trade Name
3A Medical
Generic Name
Surgical gown, single-use
Model / Reference
S4001
Description
Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407
Primary DI / UDI-DI
00850029191056
FDA Product Code
FYA
GMDN Term
Surgical gown, single-use
Device Class
Class II
Regulation Number
878.4040
Commercial Distribution
Not in Commercial Distribution

Other devices from 3A Medical Products Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 9bd1b46a-1a0c-4e63-8377-65d32df9cecc 36 fields · synced 22 Oct 2026