Duns Number:688282516
Device Description: INFINI MFR TIP A-49 1 ea(MFR 49 Tip)
Catalog Number
-
Brand Name
N/A
Version/Model Number
TIP A-49 1 ea
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
368e2e9c-e69f-486f-bea8-1652c59f2762
Public Version Date
July 26, 2021
Public Version Number
4
DI Record Publish Date
November 18, 2016
Package DI Number
8809447651774
Quantity per Package
1
Contains DI Package
08809447651781
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 145 |