Duns Number:482661753
Device Description: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm Blac HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm Black/Blue DYNATAPE Braided Flat Suture, 36inch (91 cm) and (1) White/Blue/Green, Size 2 (5 metric) DYNACORD Braided Suture, 36inch (91cm), (1) Utility Shuttle Suture BLACK 6.5mm
Catalog Number
280737
Brand Name
HEALIX ADVANCE DYNATAPE DYNACORD
Version/Model Number
280737
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
K200949
Product Code
MAI
Product Code Name
Fastener, fixation, biodegradable, soft tissue
Public Device Record Key
f5fecf91-ac24-44c2-b053-c799a7969d82
Public Version Date
February 23, 2021
Public Version Number
2
DI Record Publish Date
October 14, 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 | 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 |