Duns Number:961027315
Device Description: Convertors Stockinette
Catalog Number
1584
Brand Name
CONVERTORS
Version/Model Number
1584
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
ILG
Product Code Name
STOCKING, ELASTIC
Public Device Record Key
6bff5ec0-9943-464c-a794-f67bfabf48c1
Public Version Date
August 28, 2019
Public Version Number
1
DI Record Publish Date
August 20, 2019
Package DI Number
20192253020684
Quantity per Package
10
Contains DI Package
00192253020680
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 | 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 |