Duns Number:121622872
Device Description: Ranfac Injection Needle, F/G, SterileP/N 74343-01M
Catalog Number
RIN-11-11
Brand Name
RIN-11-11, Component Two
Version/Model Number
11 Gauge x 11cm
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"
Yes
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
FGY
Product Code Name
Cannula, Injection
Public Device Record Key
08ad025d-e9db-41aa-9a79-5414c1d257af
Public Version Date
August 27, 2019
Public Version Number
1
DI Record Publish Date
August 19, 2019
Package DI Number
10857878007863
Quantity per Package
1
Contains DI Package
00857878007866
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 93 |