Duns Number:216344051
Device Description: Thin hydrocolloid wound dressing
Catalog Number
59484200
Brand Name
REPLICaRE THIN DRESS 6X8IN
Version/Model Number
59484200
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)
-
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
f0d26347-668e-48f0-9501-a120e24ae022
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
October 07, 2020
Package DI Number
00040565115870
Quantity per Package
5
Contains DI Package
00040565115573
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |