Getinge Pack Self-Seal Pouch - Self-Seal Pouch 10cm x 28cm - PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Duns Number:565751992

Device Description: Self-Seal Pouch 10cm x 28cm

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More Product Details

Catalog Number

61301606723

Brand Name

Getinge Pack Self-Seal Pouch

Version/Model Number

GUKP1028

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152669,K152669,K152669

Product Code Details

Product Code

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

7d31d123-1936-40b3-9e8d-698abfd6572a

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 29, 2017

Additional Identifiers

Package DI Number

10850144008014

Quantity per Package

15

Contains DI Package

00850144008017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6