Reinforce Surgical Gown (AAMI Level 3)

GUDID 06973062320345

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
Primary Device ID06973062320345
NIH Device Record Keye62d3c71-e920-4f54-83ed-a7654be5ad33
Commercial Distribution StatusIn Commercial Distribution
Brand NameReinforce Surgical Gown (AAMI Level 3)
Version Model NumberPM5015RGN
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
GS106973062320345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


[06973062320345]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-06
Device Publish Date2021-09-28

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

16973062320199PM5005RGS
16973062320182PM5004RGS
16973062320175PM5003RGS
16973062320168PM5002RGS
16973062320151PM5001RGS
06973062320147PM5005RGN
06973062320130PM5004RGN
06973062320123PM5003RGN
06973062320116PM5002RGN
06973062320109PM5001RGN
16973062320397PM5015RGS
16973062320380PM5014RGS
16973062320373PM5013RGS
16973062320366PM5012RGS
16973062320359PM5011RGS
06973062320345PM5015RGN
06973062320338PM5014RGN
06973062320321PM5013RGN
06973062320314PM5012RGN
06973062320307PM5011RGN

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