AccessGUDID - DEVICE: Trabectome Handpiece (00854028002092)

GUDID

Device Identifier (DI) Information

Brand Name: Trabectome Handpiece
Version or Model: 550035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550035-01
Company Name: NEOMEDIX CORPORATION

Primary DI Number: 00854028002092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945496792 *Terms of Use

Device Description: The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic surgery. The handpiece is designed to surgically remove a strip of trabecular meshwork for surgical management of infantile and adult glaucoma. The handpiece is packaged in a surgical procedure pack containing multiple components intended to be utilized in ophthalmic surgery.

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):	Yes
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?
44681	Electrosurgical handpiece, single-use	A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 91325025-2fc7-4464-9f75-e8039a1334fe
Public Version Date: April 04, 2023
Public Version Number: 5
DI Record Publish Date: September 28, 2016