Standard Surgical Gown (AAMI Level 3)

GUDID 06973062320024

Foshan Nanhai Plus Medical Co., Ltd

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use
Primary Device ID06973062320024
NIH Device Record Key55b54c46-7bb8-4222-9770-925cbeb60182
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Surgical Gown (AAMI Level 3)
Version Model NumberPM5003SGN
Company DUNS529796225
Company NameFoshan Nanhai Plus Medical 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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106973062320024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


[06973062320024]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-08
Device Publish Date2021-08-31

On-Brand Devices [Standard Surgical Gown (AAMI Level 3) ]

16973062320090PM5005SGS
16973062320083PM5004SGS
16973062320076PM5003SGS
16973062320069PM5002SGS
16973062320052PM5001SGS
06973062320048PM5005SGN
06973062320031PM5004SGN
06973062320024PM5003SGN
06973062320017PM5002SGN
06973062320000PM5001SGN
16973062320298PM5015SGS
16973062320281PM5014SGS
16973062320274PM5013SGS
16973062320267PM5012SGS
06973062320253PM5011SGS
06973062320246PM5015SGN
06973062320239PM5014SGN
06973062320222PM5013SGN
06973062320215PM5012SGN
06973062320208PM5011SGN

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