Duns Number:058614483
Device Description: Fixation Device;20 Violet Absorbable Tacks
Catalog Number
ABSTACK20
Brand Name
AbsorbaTack
Version/Model Number
ABSTACK20
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
5e409812-5a4a-4195-8cf4-32dc6fca8571
Public Version Date
May 10, 2022
Public Version Number
6
DI Record Publish Date
August 31, 2015
Package DI Number
10613830159380
Quantity per Package
6
Contains DI Package
00613830159383
Package Discontinue Date
October 02, 2019
Package Status
Not 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 |