AccessGUDID - DEVICE: Greenwald Surgical Company, Inc. (10801334013004)

GUDID

Device Identifier (DI) Information

Brand Name: Greenwald Surgical Company, Inc.
Version or Model: 33602-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U432RS
Company Name: GRACE MANUFACTURING, INC.

Primary DI Number: 10801334013004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607903382 *Terms of Use

Device Description: Teflon insulation. Tungsten alloy cutting wire. Resectoscope Cutting Loop. Compatible with ACMI USA/Elite adult resctoscopes.

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
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: Yes
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
Device Size Text, specify: Sheath:28 French
Device Size Text, specify: Wire Diameter:0.014"
Angle: 80 degree

Device Record Status

Public Device Record Key: a7991f5f-7479-4a11-a637-5f088f1da6cd
Public Version Date: February 07, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016