Duns Number:002348191
Device Description: HEAD HARNESS - ADULT
Catalog Number
9912001
Brand Name
RUSCH
Version/Model Number
IPN049976
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
BTK
Product Code Name
STRAP, HEAD, GAS MASK
Public Device Record Key
1e7eb85f-8b1c-4682-958e-1b9d870b12a2
Public Version Date
August 19, 2020
Public Version Number
2
DI Record Publish Date
April 24, 2019
Package DI Number
34026704641537
Quantity per Package
100
Contains DI Package
14026704641533
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |