Duns Number:058614483
Device Description: Fixation Device;20 Violet Absorbable Tacks
Catalog Number
-
Brand Name
AbsorbaTack
Version/Model Number
ABSTACK20S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K091900,K091900
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
cdc4414b-7cad-4a1a-9125-7ca6b3139a5d
Public Version Date
July 26, 2021
Public Version Number
6
DI Record Publish Date
August 31, 2015
Package DI Number
20884523006152
Quantity per Package
6
Contains DI Package
10884523006155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |