Duns Number:211352227
Device Description: Non-Adhering Dressing
Catalog Number
2012
Brand Name
ADAPTIC®
Version/Model Number
2012
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
9b36e4de-d252-48ce-9e90-9d9ed08f18fd
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2019
Package DI Number
25051978000195
Quantity per Package
50
Contains DI Package
15051978000198
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 66 |
U | Unclassified | 12 |