Puresense Med

GUDID 08683105129337

STERILE GOWN

PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI

Surgical gown, single-use
Primary Device ID08683105129337
NIH Device Record Key3a7d3dd8-e632-4390-adf7-f9659dce703d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuresense Med
Version Model NumberPSM103-L
Company DUNS533154912
Company NamePURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108683105129337 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-10
Device Publish Date2021-12-31

On-Brand Devices [Puresense Med]

08683105129450STERILE GOWN
08683105129443STERILE GOWN
08683105129436STERILE GOWN
08683105129429STERILE GOWN
08683105129412STERILE GOWN
08683105129351STERILE GOWN
08683105129344STERILE GOWN
08683105129337STERILE GOWN
08683105129320STERILE GOWN
08683105129313STERILE GOWN

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