Disposable Surgical Gowns

GUDID 06938024400138

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

Surgical gown, single-use
Primary Device ID06938024400138
NIH Device Record Key1adc5852-1b59-40b1-b49a-52aca57f6ee5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Surgical Gowns
Version Model NumberSUM201022-L
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106938024400138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-04-20
Device Publish Date2021-04-09

On-Brand Devices [Disposable Surgical Gowns]

06938024400121XL
06938024400138SUM201022-L

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