Duns Number:080361159
Device Description: 72" Gait Belt, Metal Buckle, Pastel
Catalog Number
-
Brand Name
PRIMO
Version/Model Number
GB72MBP
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
b7767365-ea07-4b0f-a5c0-2a9e9e12799e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 08, 2022
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 | 1046 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |
U | Unclassified | 2 |