FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770498758
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E2428
Catalog number
E2428
Device description
AWH SUTURELESS SCLEROTOMY GDE
Published
2025-08-04
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
HMQMarker, Sclera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMQMarker, ScleraOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770498758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770498758007577704987587577704987580757770498758

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
DM exempt
true
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
00194613022297MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613084059MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086541MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086558MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086565MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086572MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087197MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087487MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087524MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613099817MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613101473MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110345MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110659MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111151MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111304MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111526MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121372MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121426MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613123697MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00810123483662Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00810123483655Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00194613086534MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613087265MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613109660MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111168MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111892MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613040918MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040925MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040932MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040949MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15