AccessGUDID - DEVICE: SlimTip™ (05415067027146)

GUDID

Device Identifier (DI) Information

Brand Name: SlimTip™
Version or Model: MN10350-90A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MN10350-90A
Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Primary DI Number: 05415067027146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021675699 *Terms of Use

Device Description: DRG Trial Lead Kit

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
PMP	Dorsal root ganglion stimulator for pain relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150004	005

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 -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 90.0000 Centimeter

Device Record Status

Public Device Record Key: 099d0ecc-c0ee-44ca-bea7-dde690b24ba1
Public Version Date: February 01, 2024
Public Version Number: 5
DI Record Publish Date: July 21, 2017