AccessGUDID - DEVICE: MediMax Tech (00817325023535)

GUDID

Device Identifier (DI) Information

Brand Name: MediMax Tech
Version or Model: OMX52P ESU Plate
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIMAX TECH INC.

Primary DI Number: 00817325023535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 927071162 *Terms of Use

Device Description: OMX52P- Split (dual), Horizontal, Corded, Cloth, Adult Grounding Plate- with New Oversized Gel - Each

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?
58494	Electrosurgical return electrode, single-use	A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use 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 [?]
K073360	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5040bbd8-bf0a-4e32-8111-2a262cf7bb0c
Public Version Date: June 05, 2020
Public Version Number: 2
DI Record Publish Date: February 20, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20817325023539	8	10817325023532	In Commercial Distribution	Master Case
10817325023532	25	00817325023535	In Commercial Distribution	Inner Box
30817325023536	10	00817325023535	In Commercial Distribution	Inner Box