Duns Number:565751992
Device Description: Self-Seal Pouch 10cm x 28cm
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
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
FRG
Product Code Name
Wrap, Sterilization
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
Package DI Number
10850144008014
Quantity per Package
15
Contains DI Package
00850144008017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |