Duns Number:005036025
Device Description: The Ritter 230 Security Straps are intended to help improve safety by securing the patient The Ritter 230 Security Straps are intended to help improve safety by securing the patient to the chair before, during and after procedures, especially when anesthesia is used. The length and location of the straps are both adjustable allowing them to be used for patients of all sizes.
Catalog Number
9A214001
Brand Name
Ritter
Version/Model Number
9A214001
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMQ
Product Code Name
Restraint, protective
Public Device Record Key
e006ac5a-fdd3-4349-a7b7-9601d735f833
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |