Duns Number:690535422
Catalog Number
-
Brand Name
TORAYGUIDE GUIDEWIRE
Version/Model Number
TRG-25230
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
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
21e92138-d8d3-4a2c-be4f-ed65429d071c
Public Version Date
November 30, 2021
Public Version Number
3
DI Record Publish Date
July 22, 2016
Package DI Number
14960685200795
Quantity per Package
1
Contains DI Package
04960685200798
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |
3 | A medical device with high risk that requires premarket approval | 3 |