AccessGUDID - DEVICE: Trabectome I/A Console (110V) (00854028002023)

GUDID

Device Identifier (DI) Information

Brand Name: Trabectome I/A Console (110V)
Version or Model: 550014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550014-01
Company Name: NEOMEDIX CORPORATION

Primary DI Number: 00854028002023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945496792 *Terms of Use

Device Description: The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.

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?
36586	Ophthalmic irrigation/aspiration pump	A mains electricity (AC-powered), ophthalmic device used to irrigate the area pertaining to the eye and eye cavity with a fluid to provide a flushing effect during ophthalmic surgery and also to aspirate by drawing liquid out of the pertinent area. It will be used for the removal of, e.g., debris, tissue or fluids from the site, and will assist the operator by keeping the site cleared and improving the field of observation. It is commonly used during cataract operations and can generate a positive and/or negative pressure with its pumping systems and is used together with compatible instruments. This device must operate at extremely low pressure to avoid inadvertent damage to the site.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or 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: No
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: 22f4d2dd-06dc-4160-89b5-a8e97f4512d1
Public Version Date: December 16, 2019
Public Version Number: 4
DI Record Publish Date: September 28, 2016