Duns Number:088189175
Device Description: Mermaid Medical® Guidewire .035” x 90 cm, 7.5 cm (Straight Tip)
Catalog Number
G60135090
Brand Name
Mermaid Medical® Guidewire
Version/Model Number
G60135090
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
K053251,K053251
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
b311b790-909c-47d2-b39a-cce7191b2fb0
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
20850758007004
Quantity per Package
10
Contains DI Package
00850758007000
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. | 1 |