Duns Number:071595540
Device Description: GENESYS CROSSFT 6.5MM SUTURE ANCHOR, W/ 3 HI-FI #2 (5 METRIC) SUTURES W/NEEDLES
Catalog Number
CFBC-6503N
Brand Name
GENESYS CROSSFT
Version/Model Number
CFBC-6503N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 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
K101100
Product Code
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
0d2257d4-1755-482f-bc37-9ea41ecbc114
Public Version Date
June 09, 2022
Public Version Number
6
DI Record Publish Date
October 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |