Duns Number:015108087
Device Description: POUCH VALULINE 3.5X9 BX500
Catalog Number
-
Brand Name
ValuLine
Version/Model Number
4756-418
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)
Yes
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
6645aae1-d54d-4b94-9899-c37d38ef6ddc
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10366975003000
Quantity per Package
4
Contains DI Package
00366975003003
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 | 1364 |
2 | A medical device with a moderate to high risk that requires special controls. | 377 |
U | Unclassified | 15 |