AccessGUDID - DEVICE: Surgilum (B836IRT1010)

GUDID

Device Identifier (DI) Information

Brand Name: Surgilum
Version or Model: IRT101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IRT101
Company Name: Surgilum, LLC

Primary DI Number: B836IRT1010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079726409 *Terms of Use

Device Description: A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use 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:	Yes
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?
61739	Corneal marker handpiece tip	A sterile device intended to be fitted to a corneal marker handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is typically a small device preloaded with ink. This is a single-use 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: 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: c5c66de5-c181-44e7-b4be-73c9e9c1afad
Public Version Date: December 10, 2021
Public Version Number: 2
DI Record Publish Date: September 21, 2021