AccessGUDID - DEVICE: CONMED (20653405031069)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: T229-5M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T229-5M
Company Name: Conmed Corporation

Primary DI Number: 20653405031069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 30653405031066

Device Description: REUSABLE GROUNDING PAD CABLES

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?
63401	Electrosurgical return lead	An insulated metal wire(s) intended to connect an electrosurgical return electrode (not included) to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during monopolar electrosurgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942215	000

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
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 490f1621-58fe-4d14-bde9-65b71a7ef1c8
Public Version Date: March 27, 2024
Public Version Number: 2
DI Record Publish Date: October 12, 2023