AccessGUDID - DEVICE: Infinion™ Pro (00191506018733)

GUDID

Device Identifier (DI) Information

Brand Name: Infinion™ Pro
Version or Model: SC-2318-70
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M365SC2318700
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 00191506018733
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: Lead Kit 16 Contact 70cm

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 [?]
P030017	354
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
Length: 70 Centimeter

Device Record Status

Public Device Record Key: 765ae0cf-a11b-43d5-8911-c947fc150df2
Public Version Date: April 30, 2024
Public Version Number: 1
DI Record Publish Date: April 22, 2024