FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770455867
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E3097
Catalog number
E3097
Device description
PUNCH AND HANDLE SET COTTINGHA
Published
2024-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00757770455867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770455867007577704558677577704558670757770455867

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

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
00192896120235Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120242Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120259Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00194613040833MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2024-08-15