Duns Number:137354267
Device Description: Fashion Arm Sling, X-Large Box 10
Catalog Number
00-1796-014-10
Brand Name
N/A
Version/Model Number
00-1796-014-10
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
ILI
Product Code Name
Sling, Arm
Public Device Record Key
1543373c-40db-4218-8f8c-f105a7f6b187
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
00889024378766
Quantity per Package
10
Contains DI Package
00889024371101
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 | 1447 |
2 | A medical device with a moderate to high risk that requires special controls. | 96 |