TalWire

GUDID 07290019773009

EMBRACE MEDICAL LTD

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual
Primary Device ID07290019773009
NIH Device Record Keyb6027287-ca7c-4fdf-895d-42f77f27ada8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalWire
Version Model NumberSP-4003-002
Company DUNS532377560
Company NameEMBRACE MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter
Guidewire Diameter0.018 Inch
Guidewire Length40 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290019773009 [Primary]
GS117290019773006 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-10
Device Publish Date2023-08-02

On-Brand Devices [TalWire]

17290019773037SP-4003-008
17290019773020SP-4003-006
17290019773013SP-4003-004
07290019773009SP-4003-002

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.