AccessGUDID - DEVICE: Attain Ability™ Straight MRI SureScan™ (00643169860223)

GUDID

Device Identifier (DI) Information

Brand Name: Attain Ability™ Straight MRI SureScan™
Version or Model: 439678
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169860223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: LEAD 439678 MRI STRAIGHT US

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
60910	Coronary venous pacing lead	An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted cardiac resynchronization therapy (CRT) pulse generator to the left ventricle of the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is introduced into a cardiac vein through transvenous approach via the coronary sinus. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTB	permanent pacemaker Electrode
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080006	095

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 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: exactly 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 78.0 Centimeter

Device Record Status

Public Device Record Key: 05733f82-bfa3-4e0b-aa0c-79a5dc5de3f8
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: March 26, 2017