Duns Number:315768788
Device Description: PROXIMEL BASIC 7x7 5/BX
Catalog Number
-
Brand Name
PROXIMEL BASIC 7x7 5/BX
Version/Model Number
15713115
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)
-
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
37d32972-b37f-45c2-b212-f4a8de8fffac
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
20612553023777
Quantity per Package
5
Contains DI Package
10612553023770
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 | 99 |
U | Unclassified | 1 |