Duns Number:026301221
Device Description: BELLA STRONG 15-20 MM HG GLOVES SIZE 6 BLACK 1
Catalog Number
7520035
Brand Name
JOBST Bella
Version/Model Number
7520035
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"
-
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
MDR
Product Code Name
BINDER, MEDICAL, THERAPEUTIC
Public Device Record Key
378664f7-9620-4c8e-8647-2a9270362a13
Public Version Date
May 20, 2022
Public Version Number
5
DI Record Publish Date
August 21, 2017
Package DI Number
00035664026165
Quantity per Package
10
Contains DI Package
00035664025625
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3716 |