AccessGUDID - DEVICE: RoboMarker G2 (B836RMSG2)

GUDID

Device Identifier (DI) Information

Brand Name: RoboMarker G2
Version or Model: RMSG2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RMSG2
Company Name: Surgilum, LLC

Primary DI Number: B836RMSG2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079726409 *Terms of Use

Device Description: A manually-operated instrument intended to be used with a disposable handpiece tip (no included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-leveling mechanism intended to accept the ink-loaded tip; it include a battery powered fixation light intended to draw the patient's focus and a projected laser target to assist with accuracy during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.

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):	No
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?
61740	Corneal marker handpiece	A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it may include a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMR	Marker, Ocular

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: 5d667f33-77b0-4980-8b57-931847fe8209
Public Version Date: August 10, 2022
Public Version Number: 1
DI Record Publish Date: August 02, 2022