AccessGUDID - DEVICE: HeartMate 3™ (05415067038432)

GUDID

Device Identifier (DI) Information

Brand Name: HeartMate 3™
Version or Model: 10010372GBL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10010372GBL
Company Name: Thoratec Corporation

Primary DI Number: 05415067038432
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use
Previous DI: 00813024013143

Device Description: Tunneling Lance and Handle

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":	No
For Single-Use:	No
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?
35950	Vascular graft tunneller	A long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSQ	Ventricular (assist) bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160054	007

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11746482-f853-4d79-a7e1-55f8de4f88c6
Public Version Date: October 05, 2022
Public Version Number: 1
DI Record Publish Date: September 27, 2022