Duns Number:152680815
Device Description: Nonsterile Coated Line Clamp, single external use
Catalog Number
C4522
Brand Name
Lifemed Coated Line Clamp
Version/Model Number
C4522
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FKK
Product Code Name
Clamp, Line
Public Device Record Key
e739c0a1-ede5-43f5-94ec-5fc18caeb08b
Public Version Date
June 05, 2020
Public Version Number
2
DI Record Publish Date
March 20, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |