AccessGUDID - DEVICE: CORNEAL TREPHINE HANDLE (00192896013193)

GUDID

Device Identifier (DI) Information

Brand Name: CORNEAL TREPHINE HANDLE
Version or Model: 12-2268
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12-2268
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896013193
Issuing Agency: GS1
Commercial Distribution End Date: July 25, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: CORNEAL TREPHINE HANDLE

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?
14148	Corneal trephine, reusable	An ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylinder, of different diameters, having a circular, saw-like working edge. It is an exchangeable device that may be attached to a manually rotated handle or to a powered rotary surgical handpiece. This device is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRH	Trephine, manual, 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 [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: For 5 Millimeter Blade

Device Record Status

Public Device Record Key: 638776cc-994b-4433-8bc1-4456d529d272
Public Version Date: July 26, 2023
Public Version Number: 2
DI Record Publish Date: September 18, 2018