DEVICE: Medetz Surgical Instruments (G223120132T0)
Device Identifier (DI) Information
Medetz Surgical Instruments
12-0132t
In Commercial Distribution
Medetz Surgical Instruments LLC
12-0132t
In Commercial Distribution
Medetz Surgical Instruments LLC
Thornton Fixation Ring: Swivel 13mm C Style with 15 Degree Markings, Round Handle, TITANIUM with Short Handle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
63521 | Ophthalmic angular gauge, reusable |
A non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HMR | Marker, Ocular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9dc6f509-831d-43de-8188-5567765d92ca
June 19, 2023
2
February 24, 2022
June 19, 2023
2
February 24, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8004205135
emichaels@medetzsurgical.com
emichaels@medetzsurgical.com