AccessGUDID - DEVICE: NESS L300-Plus System (07290110483029)

GUDID

Device Identifier (DI) Information

Brand Name: NESS L300-Plus System
Version or Model: L3P-5101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 501-00126-01
Company Name: BIONESS INC.

Primary DI Number: 07290110483029
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 182287727 *Terms of Use

Device Description: L300 Plus US Upgrade System Kit, Left (regular)

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35725	Gait-enhancement electrical stimulation system, external	An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, muscle, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Degrees Celsius
Storage Environment Temperature: between -25 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9e22560-b1b8-42aa-9d2f-5d0a02d5599b
Public Version Date: September 20, 2021
Public Version Number: 5
DI Record Publish Date: February 02, 2017