FDA.reportPublic FDA data

Coronet

Primary DI
00855934007072
Brand
Coronet
Company
CorneaGen LLC
Model
SLS-10-800
Device description
Recipient Vacuum Trephine - 8.00mm
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00855934007072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855934007072008559340070728559340070720855934007072

GMDN Terms#

Term, Definition table
TermDefinition
Corneal trephine, single-useA sterile, ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylinder, of different diameters, having a circular, saw-like working edge. It is an exchangeable device that may be attached to a manually rotated handle or to a powered rotary surgical handpiece. This is a single-use device typically made of high-grade stainless steel.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080423639
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855934007010CoronetSLS-10-6502024-06-14
00855934007027CoronetSLS-10-6752024-06-14
00855934007034CoronetSLS-10-7002024-06-14
00855934007041CoronetSLS-10-7252024-06-14
00855934007058CoronetSLS-10-7502024-06-14
00855934007065CoronetSLS-10-7752024-06-14
00855934007089CoronetSLS-10-8252024-06-14
00855934007096CoronetSLS-10-8502024-06-14
00855934007102CoronetSLS-10-8752024-06-14
00855934007119CoronetSLS-10-9002024-06-14
00855934007126CoronetSLS-10-9502024-06-14
00855934007133CoronetSLS-20-6002024-06-14
00855934007140CoronetSLS-20-6252024-06-14
00855934007157CoronetSLS-20-6502024-06-14
00855934007164CoronetSLS-20-6752024-06-14
00855934007171CoronetSLS-20-7002024-06-14
00855934007188CoronetSLS-20-7252024-06-14
00855934007195CoronetSLS-20-7502024-06-14
00855934007201CoronetSLS-20-7752024-06-14
00855934007218CoronetSLS-20-8002024-06-14

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