Duns Number:025460908
Device Description: NEURO ACCESSORY KIT
Catalog Number
VASC1171
Brand Name
Medline Industries, Inc.
Version/Model Number
VASC1171
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
OJG
Product Code Name
Neurological tray
Public Device Record Key
21ae9432-cd96-484a-9cec-a2127773d7e5
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
September 30, 2018
Package DI Number
40889942974017
Quantity per Package
12
Contains DI Package
10889942974016
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 |