Duns Number:058614483
Device Description: Violet Standard Purchase Absorable Tacks
Catalog Number
-
Brand Name
ReliaTack
Version/Model Number
RELTACK10RSW
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
K140609,K140609,K140609
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
102ea363-2edf-42f5-bd3a-5bc7a12b5ea9
Public Version Date
October 27, 2022
Public Version Number
6
DI Record Publish Date
March 09, 2018
Package DI Number
20884521726335
Quantity per Package
6
Contains DI Package
10884521726338
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |