FDA.reportPublic FDA data

Ophtec

Primary DI
05056100703766
Brand
Ophtec
Company
NETWORK MEDICAL PRODUCTS LIMITED
Model
OT16900
Device description
Ophtec Long Handled Trephine 9.00mm - Carton
Published
2019-08-30
Public version status
Update
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
05056100703766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056100703766050561007037665056100703766

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
458670304
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060165012305Eyetec40-4162019-08-06
05056100707177Eyetec1-4162020-02-25
05060165013166NETCELL37-4162019-08-28
05056100712775Lions World Vision InstituteLWVI-850-6.002025-03-11
05056100712782Lions World Vision InstituteLWVI-850-6.252025-03-11
05056100712805Lions World Vision InstituteLWVI-850-9.502025-03-11
05056100712812Lions World Vision InstituteLWVI-850-6.502025-03-11
05056100712829Lions World Vision InstituteLWVI-850-6.752025-03-11
05056100712836Lions World Vision InstituteLWVI-850-7.002025-03-11
05056100712843Lions World Vision InstituteLWVI-850-7.252025-03-11
05056100712850Lions World Vision InstituteLWVI-850-7.502025-03-11
05056100712867Lions World Vision InstituteLWVI-850-7.752025-03-11
05056100712874Lions World Vision InstituteLWVI-850-8.002025-03-11
05056100712881Lions World Vision InstituteLWVI-850-8.252025-03-11
05056100712904Lions World Vision InstituteLWVI-850-8.752025-03-11
05056100712911Lions World Vision InstituteLWVI-850-9.002025-03-11
05056100712928Lions World Vision InstituteLWVI-850-9.252025-03-11
05056100712935Lions World Vision InstituteLWVI-850-6.002025-03-11
05056100712942Lions World Vision InstituteLWVI-850-6.252025-03-11
05056100712799Lions World Vision InstituteLWVI-850-9.752025-03-11

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