AccessGUDID - DEVICE: Cadwell Disposable Monopolar Probe (00840067101834)

GUDID

Device Identifier (DI) Information

Brand Name: Cadwell Disposable Monopolar Probe
Version or Model: 302427-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CADWELL INDUSTRIES, INC.

Primary DI Number: 00840067101834
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 098554157 *Terms of Use

Device Description: No description.

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":	Yes
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?
61089	Nerve-locating system probe, single-use	A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	ELECTRODE, NEEDLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103128	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 90 Millimeter

Device Record Status

Public Device Record Key: 8281f23d-d13c-4464-a45a-543a51f662d5
Public Version Date: January 09, 2024
Public Version Number: 6
DI Record Publish Date: September 05, 2016