AccessGUDID - DEVICE: Greenwald Surgical Company, Inc. (10801334005740)

GUDID

Device Identifier (DI) Information

Brand Name: Greenwald Surgical Company, Inc.
Version or Model: 77000-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M25SB
Company Name: GRACE MANUFACTURING, INC.

Primary DI Number: 10801334005740
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607903382 *Terms of Use

Device Description: fits Bovie Specialist

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?
46429	Electrical-only medical device connection cable, reprocessed	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBJ	Cord, Electric For Transurethral Surgical Instrument

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
No Device Sizes

Device Record Status

Public Device Record Key: 9227eb56-0d7a-4214-b8bc-d54272b9aa5d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016