AccessGUDID - DEVICE: MytaMed (00841019110225)

GUDID

Device Identifier (DI) Information

Brand Name: MytaMed
Version or Model: ME3604-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Mytamed, Inc.

Primary DI Number: 00841019110225
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 015903922 *Terms of Use

Device Description: Malleable Monopolar Probe with 2.25mm Ball-Tip 100mm electrode (handle to tip) 2m cable with DIN42802 Connector

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:	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?
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	Electrode, Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100912	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7a2271a-78f8-49a0-bc77-f8399087f515
Public Version Date: June 25, 2025
Public Version Number: 5
DI Record Publish Date: July 10, 2016