Duns Number:256880576
Device Description: MEDICOM SAFEBASICS TRIANGULAR BANDAGES 40 X 40 X 56 Inch
Catalog Number
5460
Brand Name
MEDICOM SAFEBASICS
Version/Model Number
5460
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
ILI
Product Code Name
SLING, ARM
Public Device Record Key
1161cf06-2be1-4197-9a2f-9474a9433ab6
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 16, 2019
Package DI Number
12686864048843
Quantity per Package
12
Contains DI Package
10686864048845
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |