AccessGUDID - DEVICE: MR PHACO (G412PH6363R0)

GUDID

Device Identifier (DI) Information

Brand Name: MR PHACO
Version or Model: PH6363R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Crestpoint Management Limited

Primary DI Number: G412PH6363R0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836285668 *Terms of Use

Device Description: Haefliger Phaco Cleaver, For use in Left hand, Angled 10mm from bend to tip, Round Knurled Handle, 115mm Overall Length, Stainless Steel

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?
42595	Soft-tissue surgical hook, reusable	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNQ	Hook, 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: 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: 0c592092-25f7-48f0-a1c7-2c678a7e1a72
Public Version Date: June 11, 2025
Public Version Number: 1
DI Record Publish Date: June 03, 2025