AccessGUDID - DEVICE: Greenwald Surgical Company, Inc. (10801334001124)

GUDID

Device Identifier (DI) Information

Brand Name: Greenwald Surgical Company, Inc.
Version or Model: 23630-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U437GR
Company Name: GRACE MANUFACTURING, INC.

Primary DI Number: 10801334001124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607903382 *Terms of Use

Device Description: ACMI/USA resectoscope electrode; Grooved Roller

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?
61876	Open-surgery electrosurgical electrode, monopolar, reusable	An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical 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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAS	Electrode, Electrosurgical, Active, Urological

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sheath size 24 French

Device Record Status

Public Device Record Key: 6b8c05ed-633d-4406-ae10-dda3158603d3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 03, 2017