AccessGUDID - DEVICE: Ambu Neuroline Concentric Cable,Lenght of leadwire: 200 cm (79") (05707480000043)

GUDID

Device Identifier (DI) Information

Brand Name: Ambu Neuroline Concentric Cable,Lenght of leadwire: 200 cm (79")
Version or Model: 1742
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1742
Company Name: Ambu A/S

Primary DI Number: 05707480000043
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Lead Wire Length: 200 cm (80") Connector: DIN (60130-9)

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:	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?
35750	Analytical non-scalp cutaneous lead	An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG) and is not a dedicated neuromuscular transmission (NMT) lead set. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 200 Centimeter

Device Record Status

Public Device Record Key: 958c5c01-478b-4860-bac4-d47de9a5cac0
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: September 21, 2016