Duns Number:625272232
Device Description: PermaLife cell culture bag, 120ml, no green vent cap
Catalog Number
PL120-2G
Brand Name
PermaLife
Version/Model Number
PL120-2G
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPZ
Product Code Name
Container, Frozen Donor Tissue Storage
Public Device Record Key
cf96a09e-4e28-45d5-b1c0-eea094b1aeb5
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 06, 2017
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |