Duns Number:071595540
Device Description: 5.5MM GENESYS CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES
Catalog Number
CFBC-5503B
Brand Name
GENESYS CROSSFT
Version/Model Number
CFBC-5503B
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
K101100
Product Code
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
45ccdb1f-84ae-4a68-8496-30b92bc99203
Public Version Date
March 21, 2019
Public Version Number
5
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 |