Duns Number:041674552
Device Description: Site-Loc, 4"x4-3/4"
Catalog Number
Not Applicable
Brand Name
MedSource Transparent Dressing
Version/Model Number
MS-11124
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
e0b95a4e-cf51-429e-9537-1ec2db9e96cb
Public Version Date
May 07, 2021
Public Version Number
1
DI Record Publish Date
April 29, 2021
Package DI Number
00840155407893
Quantity per Package
50
Contains DI Package
00816703024621
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |