Duns Number:086911794
Device Description: An elastic bandage device consisting of a long flat strip of elasticized non-latex cohesiv An elastic bandage device consisting of a long flat strip of elasticized non-latex cohesive material that is used as a wrap to support and compress a part of a patient's body.
Catalog Number
6101
Brand Name
Rip N Wrap 1"
Version/Model Number
6101
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)
-
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
cb986768-9d56-4aaf-aeac-97a8d9bb356f
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
July 12, 2019
Package DI Number
50347682610116
Quantity per Package
96
Contains DI Package
00347682610111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |