AccessGUDID - DEVICE: HeartMate 3™ (05415067039361)

GUDID

Device Identifier (DI) Information

Brand Name: HeartMate 3™
Version or Model: 106528US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106528US
Company Name: Thoratec Corporation

Primary DI Number: 05415067039361
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070156955 *Terms of Use
Previous DI: 05415067030825

Device Description: Skin Coring Punch

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:	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?
63166	Skin-coring punch, single-use	A hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically made of high-grade stainless steel and is available in various cutting head sizes; it is not a biopsy gun. This is a single-use 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	006

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1fb907d6-0aa1-4159-8280-09960f57c2aa
Public Version Date: June 22, 2022
Public Version Number: 1
DI Record Publish Date: June 14, 2022