Duns Number:216344051
Device Description: Multi-Layer Compression Bandaging System - Latex free formulation
Catalog Number
66020626
Brand Name
PROFORE KIT LATEX FREE
Version/Model Number
66020626
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)
-
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
adfe46ea-d58d-4308-ad4a-76fad6a18a53
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
April 09, 2020
Package DI Number
05000223496401
Quantity per Package
8
Contains DI Package
05031844013883
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |