FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770501274
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E2432
Catalog number
E2432
Device description
NICHAMIN DBL LRI/TORIC GAUGE
Published
2025-06-03
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
JYJGauge, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770501274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770501274007577705012747577705012740757770501274

GMDN Terms#

Term, Definition table
TermDefinition
Scleral marker, reusableA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel) or synthetic polymer material. Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. 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
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368862557Sizer OMEGA CONNECTORHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
00844505014700SKULL BASEGrace Medical, Inc.JYJ2025-09-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.JYJ2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.JYJ2025-07-02
00194613116965MSI Precision Specialty InstrumentsMed Saver, Inc.JYJ2025-03-21
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00840183527501BR Surgical, LLCBR Surgical, LLCJYJ2024-11-26
00887482114223Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-20
00887482113387Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-12
00190776378448MillenniumAvalign Technologies, Inc.JYJ2023-11-13
00844505014328BENSON UNIVERSAL IMPLANT SIZERGrace Medical, Inc.JYJ2023-09-27
00190776289232MillenniumAvalign Technologies, Inc.JYJ2023-06-23
00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
00842331131288Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-10
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04250381848456Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848463Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848470Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849453Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849460Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849477Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13