Duns Number:830016148
Device Description: 3M™ Coban™ Self-Adherent Wrap, 1583S, Sterile, 3 in x 5 yd (7,5 cm x 4,5 m), 24 Rolls/Case
Catalog Number
1583S
Brand Name
3M™ Coban™
Version/Model Number
1583S
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
b81fa0b3-b748-42fa-a3e5-4ef46fee11c2
Public Version Date
February 15, 2021
Public Version Number
1
DI Record Publish Date
February 05, 2021
Package DI Number
50707387802283
Quantity per Package
24
Contains DI Package
00707387802288
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |