AccessGUDID - DEVICE: Sensimatic™ (M595D6010)

GUDID

Device Identifier (DI) Information

Brand Name: Sensimatic™
Version or Model: D601
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D601
Company Name: PARKELL, INC.

Primary DI Number: M595D6010
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: New Indifferent Plate & Red Cable for Sensimatic™ 600SE (Complies with New FDA Lead Wire Regulations)

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?
42551	Electrosurgical return electrode, reusable	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 may be designed with permanently attached leads. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKZ	Unit, Electrosurgical, And Accessories, Dental

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam 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: 993f35a8-0a0d-46c2-8e65-3ed4cae9f3f2
Public Version Date: June 05, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016