FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770409761
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0421
Catalog number
E0421
Device description
TRAB HARMS W/HDL PAIR 1RT-1LT
Published
2025-04-21
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
HMZTrabeculotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMZTrabeculotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770409761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770409761007577704097617577704097610757770409761

GMDN Terms#

Term, Definition table
TermDefinition
Trabeculotome, reusableA hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy [surgical opening of the sinus venosus sclerae (Schlemm’s canal)] to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is typically made of high-grade stainless steel, having a two-pronged fork at the distal end and a handle at the proximal end. It enables guided unroofing of Schlemm's canal (an endothelium-lined tube) through insertion of one of the prongs via incisions and flaps made in the eye. 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
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613004057MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613007614MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613021061MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613021078MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613021085MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613111496MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613119362MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613120382MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-08-01
00194613004040MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-03-21
00194613084714MSI Precision Specialty InstrumentsMed Saver, Inc.HMZ2025-03-21
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.HMZ2025-03-06
00892064002362VIA360 Surgical SystemNEW WORLD MEDICAL, INCORPORATEDHMZ2025-02-18
00858027006433OMNI Surgical SystemSight Sciences, Inc.HMZ2023-10-17
05055313811336Duckworth & KentDUCKWORTH AND KENT LIMITEDHMZ2022-08-31
05055313811343Duckworth & KentDUCKWORTH AND KENT LIMITEDHMZ2022-08-31
05055313811350Duckworth & KentDUCKWORTH AND KENT LIMITEDHMZ2022-08-31
00858027006525OMNI Surgical SystemSight Sciences, Inc.HMZ2022-08-22
00858027006501Sion Surgical InstrumentSight Sciences, Inc.HMZ2022-08-01
00858027006358OMNI PLUSSight Sciences, Inc.HMZ2020-10-30
00858027006372OMNI(R) Surgical System (US)Sight Sciences, Inc.HMZ2020-06-01
00858027006334OMNI Surgical System (US)Sight Sciences, Inc.HMZ2019-10-25
00858027006310OMNI Surgical System (US)Sight Sciences, Inc.HMZ2018-03-16
00858027006112TRAB(TM)360 Trabeculotomy SystemSight Sciences, Inc.HMZ2016-11-23