Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1651405

FEI Number

3000892087

Entity Name

INTERNATIONAL SCIENCE AND TECHNOLOGY, LP

City/State/Country

The Woodlands, TX, US

Establishment Address

210 Nursery Rd, The Woodlands, TX 77380, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DIAMATRIX LIMITED, INC. (Owner Number: 9041339)

Owner / Operator Contact Address

210 NURSERY ROAD, The Woodlands, TX 77380, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ProTekt ExactEtch UltraEdge DIAMATRIX DIAMATRIX DIAMATRIX Xpand Iris Speculum, Xpand NT Iris Speculum, X1 Iris Speculum, X2 Iris Speculum DIAMATRIX DIAMATRIX DIAMATRIX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-05-16
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-04-06
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-04-06
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2014-01-20
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-04-06
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2004-04-06
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-04-06

Official Correspondent

Matthew Dykes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIAMATRIX LIMITED, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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2029275	Sterigenics U.S., LLC	Corona, CA, US
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1651405. Last updated year: 2026. Please use registration number 1651405 when referencing this establishment in official correspondence.