Duns Number:078388975
Device Description: Sphere 23mm w Enucleation Introducer
Catalog Number
4035
Brand Name
SU-POR Surgical Implant
Version/Model Number
4035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K140437
Product Code
FWP
Product Code Name
Prosthesis, Chin, Internal
Public Device Record Key
c95a7470-8f98-4e32-ac9a-e8dfc69a7d96
Public Version Date
September 29, 2021
Public Version Number
1
DI Record Publish Date
September 21, 2021
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. | 318 |