Duns Number:806136177
Device Description: SGW .014 STABILIZER 300CM
Catalog Number
527300E
Brand Name
STABILIZER
Version/Model Number
527300E
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
8bf8980a-435d-4acf-95cd-a669f9149539
Public Version Date
February 15, 2022
Public Version Number
2
DI Record Publish Date
January 26, 2021
Package DI Number
20705032056417
Quantity per Package
5
Contains DI Package
10705032056410
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2567 |
3 | A medical device with high risk that requires premarket approval | 204 |