FDA.reportPublic FDA data

Ophtec

Primary DI
05056100703728
Brand
Ophtec
Company
NETWORK MEDICAL PRODUCTS LIMITED
Model
OT16850
Device description
Ophtec Long Handled Trephine 8.50mm - 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
05056100703728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056100703728050561007037285056100703728

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
00810158218468PRINCETONPrinceton Medical Group, Inc.HRH2026-01-15
00852194002106HAI TrephineHightech American Industrial Labs IncHRH2025-12-16
00757770422494Bausch + LombBausch & Lomb IncorporatedHRH2025-08-08
00194613037956MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00194613111380MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00757770435432Bausch + LombBausch & Lomb IncorporatedHRH2025-07-30
G412PH98270MR PHACOCrestpoint Management LimitedHRH2025-06-09
G412PH62270MR PHACOCrestpoint Management LimitedHRH2025-05-27
05056100712935Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712942Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712799Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713079Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712959Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712966Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712973Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712980Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712997Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713000Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713017Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713024Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712898Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713048Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713055Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713062Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
00757770430345Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00757770435036Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00757770455867Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00192896120235Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120242Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120259Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15