Duns Number:482661753
Device Description: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) Black/Blue 2.5mm DYNATAPE Suture HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) Black/Blue 2.5mm DYNATAPE Suture (1) White/Blue/Green, Size 2 (5 Metric), DYNACORD Suture, 36 inch (91 cm) BLACK 6.5mm
Catalog Number
280815
Brand Name
HEALIX Ti DYNATAPE
Version/Model Number
280815
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K203794
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
7f519902-ad5b-4462-a9e3-e2dbc126f4b0
Public Version Date
March 12, 2021
Public Version Number
1
DI Record Publish Date
March 04, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |