Duns Number:025460908
Device Description: DBD-GAUZE,BORDER,4X14,(2X12PAD,)STERILE
Catalog Number
MSCG32414
Brand Name
Medline
Version/Model Number
MSCG32414
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
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
4d572554-c664-47b0-b8ea-f88ff2ecc0c9
Public Version Date
May 26, 2021
Public Version Number
1
DI Record Publish Date
May 18, 2021
Package DI Number
30888277701827
Quantity per Package
150
Contains DI Package
20888277701820
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |