AccessGUDID - DEVICE: Evans (Instruments) Limited (05060660330041)

GUDID

Device Identifier (DI) Information

Brand Name: Evans (Instruments) Limited
Version or Model: Blueray Table
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRT/BKN
Company Name: EVANS (INSTRUMENTS) LIMITED

Primary DI Number: 05060660330041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 770149789 *Terms of Use

Device Description: Ophthalmic Instrument Table - Line Powered

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?
36400	Ophthalmic instrument table, line-powered	A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRJ	Table, Instrument, Powered, Ophthalmic

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: 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: 62a1d79d-fff5-40ab-a228-637daab328e7
Public Version Date: September 23, 2024
Public Version Number: 1
DI Record Publish Date: September 14, 2024