AccessGUDID - DEVICE: ReActiv8 Stimulation Lead (05391527772064)

GUDID

Device Identifier (DI) Information

Brand Name: ReActiv8 Stimulation Lead
Version or Model: 7M8145-005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8145
Company Name: MAINSTAY MEDICAL LIMITED

Primary DI Number: 05391527772064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985519015 *Terms of Use

Device Description: Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
QLK	Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190021	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 16ee1969-03bc-4a74-aeab-95ac27d0a0e8
Public Version Date: June 08, 2021
Public Version Number: 3
DI Record Publish Date: January 25, 2021