AccessGUDID - DEVICE: Masters Series™ (05415067042293)

GUDID

Device Identifier (DI) Information

Brand Name: Masters Series™
Version or Model: M-RHR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M-RHR
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067042293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use
Previous DI: 05414734010061

Device Description: Replacement Holder/Rotators

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?
47680	Heart valve prosthesis holder, single-use	A hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTJ	HOLDER, HEART-VALVE, PROSTHESIS

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ecdae6e-25f9-4aa0-ae35-0357c87605d6
Public Version Date: February 27, 2023
Public Version Number: 1
DI Record Publish Date: February 17, 2023