AccessGUDID - DEVICE: Tru-Incise Valvulotome with Interchangeable Heads (H862TIVC0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: H862TIVC0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 17, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 192559557 *Terms of Use

Device Description: Tru-Incise Valvulotome Catheter Kit

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?
32321	Vein stripper, single-use	A sterile hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). 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 [?]
K930011	000

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
Length: 94 Centimeter

Device Record Status

Public Device Record Key: 7d8d8173-8149-4ceb-848a-83841a7e285b
Public Version Date: September 18, 2019
Public Version Number: 4
DI Record Publish Date: August 31, 2016