Duns Number:025460908
Device Description: VALIDATION KIT 4X9
Catalog Number
ENGVALKIT4
Brand Name
Medline Industries, Inc.
Version/Model Number
ENGVALKIT4
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)
Yes
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
OJH
Product Code Name
Orthopedic tray
Public Device Record Key
1b4ff7c8-0cb4-406b-9686-080a8995443d
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
August 28, 2018
Package DI Number
40080196836179
Quantity per Package
30
Contains DI Package
10080196836178
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 |