AccessGUDID - DEVICE: Greenwald Surgical Company, Inc. (10801334006877)

GUDID

Device Identifier (DI) Information

Brand Name: Greenwald Surgical Company, Inc.
Version or Model: C8855-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C8855-00
Company Name: GRACE MANUFACTURING, INC.

Primary DI Number: 10801334006877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607903382 *Terms of Use

Device Description: BOVIE PLUG TIP & BUSHING

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?
58068	Electrosurgical/ultrasonic surgical system tester interface	A non-sterile electrical connecting device designed to provide an interface between a commonly used electrical output analyser/equipment and an electrosurgical system generator and an ultrasonic surgical system generator, or a combination electrosurgical/ultrasonic surgical system generator when being tested for power output in a non-clinical setting. Commonly known as a verification key, it is typically used by a hospital clinical engineer when testing the generators during routine maintenance or inspection and provides standard connector components (e.g., banana plug receptacles) to allow simpler interface with a custom generator connector. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGI	Electrocautery, Gynecologic (And Accessories)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Liquid Chemical
Ethylene Oxide

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: 95e37aee-cdcc-4122-8124-cf3c16dc7e29
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016