AccessGUDID - DEVICE: Vectris™ SureScan® (00643169109421)

GUDID

Device Identifier (DI) Information

Brand Name: Vectris™ SureScan®
Version or Model: 977A160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169109421
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: LEAD 977A160 MRICS SUBCOMPACT

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:	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?
62423	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection	An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
QRB	Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P840001	219

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 -34 and 57 Degrees Celsius
Handling Environment Temperature: between -30 and 135 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 60.0 Centimeter

Device Record Status

Public Device Record Key: 12b1d64c-64e3-4c01-87d3-c4676c492832
Public Version Date: January 13, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2014