Duns Number:025460908
Device Description: DBD-BANDAGE,ELASTIC,SURE-WRAP,4"X5YD,CLI
Catalog Number
MDS055004ZG
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS055004ZG
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)
-
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
b80d74be-a1e5-4691-8aaf-5e2f13f4a44f
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
January 20, 2021
Package DI Number
30080196575903
Quantity per Package
10
Contains DI Package
10080196575909
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |