Duns Number:322018193
Device Description: P1210.5011 iSy® Implants-Set, 2 units d 5 mm, L 11 mm
Catalog Number
P1210.5011
Brand Name
iSy® Implants-Set
Version/Model Number
P1210.5011
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2015
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
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
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
61d02640-b324-4c58-907a-4b1134c7c215
Public Version Date
March 29, 2018
Public Version Number
2
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 | 290 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 901 |