Duns Number:002144145
Device Description: E-Pack Procedure Kit
Catalog Number
8131E
Brand Name
E-PACK
Version/Model Number
8131E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
aa42f21e-a304-40eb-859d-efe94bbe8e6b
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
September 20, 2015
Package DI Number
20705031012841
Quantity per Package
5
Contains DI Package
10705031012844
Package Discontinue Date
July 08, 2019
Package Status
Not in Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |