Duns Number:055870299
Device Description: Breast Reduction Compression Device tourniquet, for approx. 500-800gm reduction5/SET STERI Breast Reduction Compression Device tourniquet, for approx. 500-800gm reduction5/SET STERILE
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.BRC5
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
GAX
Product Code Name
Tourniquet, Nonpneumatic
Public Device Record Key
509627a2-0fe2-425e-a901-2162beb4d73d
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |