Duns Number:078572603
Device Description: Crutches Aluminum, Tall Adult, Push Button, 1 pair
Catalog Number
-
Brand Name
HCS
Version/Model Number
HCS6002A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IPR
Product Code Name
Crutch
Public Device Record Key
e8f23fb7-11f4-4c1d-a961-ed4c1fbcf374
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 30, 2020
Package DI Number
10849027000689
Quantity per Package
8
Contains DI Package
00849027000682
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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |