Duns Number:961027315
Device Description: RUBBER BANDS # 16
Catalog Number
BN14-0031
Brand Name
CARDINAL HEALTH
Version/Model Number
BN14-0031
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECI
Product Code Name
BAND, ELASTIC, ORTHODONTIC
Public Device Record Key
63eafc06-1d1e-4dee-85a9-287c6a7c0a37
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
August 29, 2016
Package DI Number
50885425323300
Quantity per Package
100
Contains DI Package
10885425323302
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 |