Duns Number:096191093
Device Description: Self Seal 7-1/2" x 14" (7-1/2" x 13") Sterilization Pouches 200/bx. - MARK3
Catalog Number
-
Brand Name
MARK3
Version/Model Number
6119
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
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
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
58e75c3d-9e9e-4151-97e0-ec2ef7abf851
Public Version Date
July 16, 2019
Public Version Number
1
DI Record Publish Date
July 08, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 96 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |
| U | Unclassified | 1 |