Duns Number:080506581
Device Description: NEUFLEX FINGER-PIP IMPLANT 1 CEMENTLESS
Catalog Number
123310000
Brand Name
NEUFLEX
Version/Model Number
1233-10-000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2022
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
K001922,K083107,K970544
Product Code
KYJ
Product Code Name
PROSTHESIS, FINGER, CONSTRAINED, POLYMER
Public Device Record Key
c18d2d23-9381-479c-a478-bed2e10eb33d
Public Version Date
March 31, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2015
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 | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |