Duns Number:025460908
Device Description: HITHRZR CRANIAL ACCESS KIT
Catalog Number
HITHRZR
Brand Name
Medline Industries, Inc.
Version/Model Number
HITHRZR
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
Yes
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
b4927268-cba6-41ef-8eef-b5440074a07f
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
January 27, 2019
Package DI Number
43828300486066
Quantity per Package
5
Contains DI Package
13828300486065
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 |