Duns Number:012430880
Device Description: Aluminum crutches, adult Tall Medx
Catalog Number
5701467
Brand Name
Henry Schein
Version/Model Number
5701467
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
9aa238f9-d273-4afc-98d3-c3a7139c1672
Public Version Date
November 12, 2019
Public Version Number
1
DI Record Publish Date
November 04, 2019
Package DI Number
10304040117856
Quantity per Package
8
Contains DI Package
00304040117859
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |