Duns Number:076059836
Device Description: Tender Tape, 2 IN x 5 YDS (50 mm x 4.5 m) stretched; 2 IN x 2.2 YDS (50 mm x 2 m)
Catalog Number
-
Brand Name
GoodSense
Version/Model Number
180410000231
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
39c4a3d8-4076-4dec-9069-7704925c5f67
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
August 28, 2020
Package DI Number
10180410000238
Quantity per Package
72
Contains DI Package
00180410000231
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |