Duns Number:961027315
Device Description: Self-Adherent Latex Bandage 3" x5yd; Sterile; For Single Use Only; Store in a cool, dry pl Self-Adherent Latex Bandage 3" x5yd; Sterile; For Single Use Only; Store in a cool, dry place. Caution: This product contains natural rubber latex which may cause allergic reactions.
Catalog Number
CAH35S
Brand Name
CARDINAL HEALTH
Version/Model Number
CAH35S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
0b3c6434-139c-418a-9700-63696f4916b8
Public Version Date
July 08, 2019
Public Version Number
1
DI Record Publish Date
June 30, 2019
Package DI Number
50885380004436
Quantity per Package
24
Contains DI Package
00885380004431
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 |