AccessGUDID - DEVICE: Tru-Incise Valvulotome with Interchangeable Heads (H862TIVH40NC0)

GUDID

Device Identifier (DI) Information

Brand Name: Tru-Incise Valvulotome with Interchangeable Heads
Version or Model: TIVH40
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TIVH40
Company Name: URESIL, LLC

Primary DI Number: H862TIVH40NC0
Issuing Agency: HIBCC
Commercial Distribution End Date: October 23, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: Tru-Incise 4mm Cutting Head

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62527	Valvulotome, percutaneous	A sterile, flexible tube with an exposable blade assembly at its distal end designed to incise/excise peripheral venous valves to allow retrograde flow of blood. It is introduced percutaneously over an in-situ guidewire into a vein before being advanced distally to the valves, where the cutting implement is exposed using controls at the proximal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGZ	Valvulotome

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4 Millimeter

Device Record Status

Public Device Record Key: 0d1c285a-deaa-442c-9bf9-5ac7b6479548
Public Version Date: December 15, 2020
Public Version Number: 2
DI Record Publish Date: September 11, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H862TIVH40NC2	10	H862TIVH40NC1	2020-10-23	Not in Commercial Distribution	Shipper
H862TIVH40NC1	1	H862TIVH40NC0	2020-10-23	Not in Commercial Distribution	Dispenser