Duns Number:876570990
Device Description: Jansen Middleton Septum Forceps Small Jaws, JL13mm WL100mm(3 7/8"), OL 160mm(6 1/4")
Catalog Number
-
Brand Name
Septum Forcep
Version/Model Number
13-2965
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
KAE
Product Code Name
Forceps, Ent
Public Device Record Key
4d74e023-8d79-423c-a247-133444b7df56
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
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 | 120 |