3A MEDICAL

GUDID 00850029191117

Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407

3A Medical Products Co.,Ltd

Surgical gown, single-use
Primary Device ID00850029191117
NIH Device Record Key519775d0-de20-4a55-b760-e66c82ed5464
Commercial Distribution Discontinuation2021-03-10
Commercial Distribution StatusNot in Commercial Distribution
Brand Name3A MEDICAL
Version Model NumberS3002
Company DUNS544515279
Company Name3A Medical Products Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com
Phone705-232-1615
Emailservice@hilo8a.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source
Special Storage Condition, SpecifyBetween 0 and 0 *avoid contact with an open flame or high intensity heat source

Device Identifiers

Device Issuing AgencyDevice ID
GS100850029191117 [Primary]

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-18
Device Publish Date2021-03-10

On-Brand Devices [3A MEDICAL]

00850029191049Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requir
00850029191032Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets require
00850029191025Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requireme
00850029191148Standard Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS
00850029191131Standard Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AST
00850029191124Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM
00850029191056Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement
00850029191018Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS
00850029191001Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM
00850029191193Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requireme
00850029191186Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen
00850029191179Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement
00850029191162Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen
00850029191155Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement
00850029191117Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS
00850029191100Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM
00850029191094Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requireme
00850029191087Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen
00850029191070Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement
00850029191063Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requiremen
00850029191230Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70
00850029191223Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AST
00850029191216ULTRA Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requireme
00850029191209Standard Surgical gown, Size LARGE , SINGLE USE ONLY, LEVEL 2 AAMI PB70

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.