Duns Number:257315713
Device Description: GAP CONICAL REAMER FOR Ø 7.2, 8.0 mm NAILS
Catalog Number
GAP-DTP052
Brand Name
GAP ENDO-EXO MEDULLARY SYSTEM
Version/Model Number
GAP-DTP052
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
-
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
HTO
Product Code Name
REAMER
Public Device Record Key
6b6a406d-0827-4212-bb1a-1075447948eb
Public Version Date
August 20, 2020
Public Version Number
1
DI Record Publish Date
August 12, 2020
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 | 375 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 825 |