Duns Number:058614483
Device Description: Violet Deep Purchase Absorbable Tacks
Catalog Number
-
Brand Name
ReliaTack
Version/Model Number
RELTACK5RDPT
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
K151659,K151659
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
5bf42073-c3a2-40f4-8e87-fda17d2228db
Public Version Date
December 17, 2021
Public Version Number
6
DI Record Publish Date
August 23, 2017
Package DI Number
10884521202405
Quantity per Package
6
Contains DI Package
20884521202402
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 |