Disposable Surgical Gowns

GUDID 06938024400121

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

Surgical gown, single-use
Primary Device ID06938024400121
NIH Device Record Key28ab9d08-1f43-4972-80b2-e047736371ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Surgical Gowns
Version Model NumberXL
Company DUNS421260215
Company NameWeihai Hongyu Nonwoven Fabric Products Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106938024400121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


[06938024400121]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-16
Device Publish Date2021-04-08

On-Brand Devices [Disposable Surgical Gowns]

06938024400121XL
06938024400138SUM201022-L

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