FDA.report

Thornton Fixation Ring

Primary DI
G22350129130
Brand
Thornton Fixation Ring
Company
Medetz Surgical Instruments LLC
Model
5-0129-13
Device description
Thornton Fixation Ring: Fixed 13mm x 7mm C Style with 10 Degree Markings, Round Knurled Handle, Stainless Steel
Published
2022-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HMRMarker, Ocular

Product Code Classifications

CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G22350129130PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic angular gauge, reusableA 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8004205135emichaels@medetzsurgical.com

Regulatory Flags

DUNS number
876570990
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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