Duns Number:199354556
Device Description: Take 1 Retraction Low Viscosity Kit, 60 Pack
Catalog Number
-
Brand Name
Take 1 Retraction Paste
Version/Model Number
36678
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
K111348
Product Code
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
563d79b3-b433-471c-9da4-cdf64fb8aca9
Public Version Date
February 23, 2021
Public Version Number
1
DI Record Publish Date
February 15, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |