Puresense Med - STERILE GOWN - PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI

Duns Number:533154912

Device Description: STERILE GOWN

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More Product Details

Catalog Number

-

Brand Name

Puresense Med

Version/Model Number

PSM103-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093835

Product Code Details

Product Code

FYA

Product Code Name

Gown, Surgical

Device Record Status

Public Device Record Key

a74542a2-48ac-4e66-a6cc-e04037668f55

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10