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
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
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