FDA.reportPublic FDA data

Corneal Trephine Blade

Primary DI
00192896105485
Brand
Corneal Trephine Blade
Company
SONTEC INSTRUMENTS, INC.
Model
12-1210
Device description
Corneal Trephine Blade
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRHTrephine, manual, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896105485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896105485001928961054851928961054850192896105485

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.75Millimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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00192896012646ALGERBRUSH DIAMOND FINE GRIT BURR11-461111-46112018-09-18
00192896012653ALGERBRUSH DIAMOND BURR11-461211-46122018-09-18
00192896012660ALGERBRUSH DIAMOND BURR11-461311-46132018-09-18
00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
00192896072398ALGERBRUSH DIAMOND BURR11-460911-46092018-09-19
00192896092792UNIVERSITY OF MINNESOTA CHEEK RETRACTOR207-210207-2102019-01-03
00192896044661BARR PROBE508-547508-5472018-09-14
00192896123397Smithwick Vasectomy Hook516-716516-7162026-05-12
00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445956165SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956172SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956189SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956196SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956202SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956219SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956226SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956233SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956240SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956257SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956264SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956271SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956288SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956295SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956301SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956318SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956325SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956332SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956349SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956356SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956363SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956370SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956387SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956394SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956400SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956417SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956424SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
00810158218468PRINCETONPrinceton Medical Group, Inc.HRH2026-01-15
00852194002106HAI TrephineHightech American Industrial Labs IncHRH2025-12-16
00810158217645PRINCETONPrinceton Medical Group, Inc.HRH2025-10-17