Duns Number:482661753
Device Description: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMA HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE Braided Flat Suture, 38" (96 cm) and (1) Blue, Size 2 (5 metric) DYNACORD Braided Suture, 36" (91cm), (1) Utility Shuttle Suture 5.5mm
Catalog Number
222464
Brand Name
HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD
Version/Model Number
222464
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
K191483
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
58310105-014c-4d91-bbb3-8bed87a928a2
Public Version Date
July 19, 2019
Public Version Number
1
DI Record Publish Date
July 11, 2019
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 |