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Diamatrix

FDA UDI

Class I (US FDA UDI)

by Diamatrix

Identity

Trade Name
Diamatrix FDA UDI
Generic Name
Eyeball fixation instrument, reusable FDA UDI
Device Name
Thornton Fixation Ring, 13mm swivel head with 7mm cutout opening in front, 10° markings visible from top of ring, Round handle, 110mm total length, Titanium FDA UDI
Model / Reference
TS13Rx7-10 FDA UDI
Description
Thornton Fixation Ring, 13mm swivel head with 7mm cutout opening in front, 10° markings visible from top of ring, Round handle, 110mm total length, Titanium FDA UDI

Identifiers

Catalog Number
TS13Rx7-10 FDA UDI
Primary DI / UDI-DI
00813059016416 FDA UDI
FDA Product Code
HMR FDA UDI
GMDN Term
Eyeball fixation instrument, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Eyeball fixation instrument, reusable

Diamatrix by Diamatrix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eyeball fixation instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diamatrix

Sources (1)

  • FDA UDI 887b2d1e-7880-4874-a041-3571b8b85183 35 fields · synced May 29, 2026