Duns Number:187502109
Device Description: ALPHAVENT SUTURE ANCHOR 4.75MM PEEK, SUTURE ANCHOR WITH 3 STRANDS 1.4MM XBRAID TT SUTURE T ALPHAVENT SUTURE ANCHOR 4.75MM PEEK, SUTURE ANCHOR WITH 3 STRANDS 1.4MM XBRAID TT SUTURE TAPE WITH MO-6 TAPERED NEEDLES
Catalog Number
3910-947-131
Brand Name
AlphaVent
Version/Model Number
3910947131
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
-
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
b229fc7a-3c66-4182-9df9-30e930865115
Public Version Date
February 18, 2022
Public Version Number
1
DI Record Publish Date
February 10, 2022
Package DI Number
37613327562973
Quantity per Package
1
Contains DI Package
07613327563115
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |