AccessGUDID - DEVICE: Linear™ (08714729784074)

GUDID

Device Identifier (DI) Information

Brand Name: Linear™
Version or Model: SC-2158-50E
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 08714729784074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: 50cm 8 Contact Trial Lead Kit

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?
63365	Implantable electrical stimulation system intraoperative test lead	A flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device.	Active	false

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 [?]
P030017	118
P030017	357
P030017	363

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 50 cm Length

Device Record Status

Public Device Record Key: 9f7bd975-47ba-421f-a790-9a2c937f2a6c
Public Version Date: August 20, 2024
Public Version Number: 4
DI Record Publish Date: December 14, 2015