Duns Number:025460908
Device Description: TRI ADAPTER KIT INSERT TORQUE
Catalog Number
DYNJHEMOKIT7
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJHEMOKIT7
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"
Yes
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
LRO
Product Code Name
General surgery tray
Public Device Record Key
c8011958-1af5-4a50-9208-81f73a19a43c
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
November 08, 2021
Package DI Number
40889942898412
Quantity per Package
25
Contains DI Package
10889942898411
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |