AccessGUDID - DEVICE: MR PHACO (G412PH9515T0)

GUDID

Device Identifier (DI) Information

Brand Name: MR PHACO
Version or Model: PH9515T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Crestpoint Management Limited

Primary DI Number: G412PH9515T0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836285668 *Terms of Use

Device Description: Intra-Op Toric Axis Marker II with two 2mm marking blades, Relief cuts on the two 180 degree positions to allow for easy alignment, 125mm Overall Length, Round Knurled Handle mounted in the 90 degree position, Titanium

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?
37896	Corneal marker, reusable	A manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 0f12c668-f74e-4d3c-a7ce-d7252c181ab6
Public Version Date: June 10, 2025
Public Version Number: 1
DI Record Publish Date: June 02, 2025