Duns Number:196548481
Device Description: Zip DS Dressing Shield
Catalog Number
PS1241
Brand Name
Zip DS Dressing Shield
Version/Model Number
PS1241
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
de53d338-2d78-4841-bf2c-427db7527b45
Public Version Date
May 06, 2021
Public Version Number
5
DI Record Publish Date
August 02, 2018
Package DI Number
10865379000054
Quantity per Package
5
Contains DI Package
00865379000057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |