Duns Number:961027315
Device Description: Bariatric Tape Measure
Catalog Number
BTM-100
Brand Name
CARDINAL HEALTH
Version/Model Number
BTM-100
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
Yes
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
FYI
Product Code Name
APPLIANCE, FACIAL FRACTURE, EXTERNAL
Public Device Record Key
f1406974-de82-4070-8643-a4e139ab6541
Public Version Date
August 27, 2020
Public Version Number
1
DI Record Publish Date
August 19, 2020
Package DI Number
50885380175891
Quantity per Package
200
Contains DI Package
20885380175890
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |