FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770498680
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E2427
Catalog number
E2427
Device description
WHITMAN DBL ENDED LRI MARKER
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HJBInstrument, Measuring, Corneal Radius

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJBInstrument, Measuring, Corneal RadiusOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770498680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770498680007577704986807577704986800757770498680

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00194613087548MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613087586MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
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00194613099572MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613099589MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613099718MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100056MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100414MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
00194613100469MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-08-01
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00194613099701MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
00194613099725MSI Precision Specialty InstrumentsMed Saver, Inc.HJB2025-03-21
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00840285320468Walcott Rx ProductsWalcott Rx Product IncHJB2022-11-23
00840285320321Walcott Rx ProductsWalcott Rx Product IncHJB2022-11-11
00840285311589Walcott Rx ProductsWalcott Rx Product IncHJB2022-08-10
00840285311596Walcott Rx ProductsWalcott Rx Product IncHJB2022-08-10