Duns Number:058614483
Device Description: Tumescent Infiltration Kit
Catalog Number
TIK-01
Brand Name
ClosureFast
Version/Model Number
TIK-01
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
-
Product Code
OEQ
Product Code Name
Angiography/angioplasty kit
Public Device Record Key
2c88c8f3-1c6d-4bb1-8bb0-cb66d41af386
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
May 26, 2017
Package DI Number
20884521140407
Quantity per Package
50
Contains DI Package
10884521140400
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 |