FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770505784
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E1308
Catalog number
E1308
Device description
STORZ IOL CUTTER
Published
2025-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRRScissors, Orthopedic, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRRScissors, Orthopedic, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770505784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770505784007577705057847577705057840757770505784

GMDN Terms#

Term, Definition table
TermDefinition
Corneal scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue (e.g., during cataract extraction surgery, corneal transplant surgery). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. 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
00846338005689CuretteELLIQUENCE, LLCHRR2026-06-02
00846338005696CuretteELLIQUENCE, LLCHRR2026-06-02
00846338005702CuretteELLIQUENCE, LLCHRR2026-06-02
08961104622838All Purpose ScissorsMELPEX BEAUTY INSTRUMENTSHRR2026-05-21
08961104622845Crown ScissorsMELPEX BEAUTY INSTRUMENTSHRR2026-05-21
04059453049223Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2026-03-02
00810207783954Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783961Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783978Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783985Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
04059453054517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2025-08-28
00194613061821MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613096328MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114121MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114671MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114688MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613115135MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613120092MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
B35675470110American MedicalsAmerican MedicalsHRR2025-06-30
B35675475110American MedicalsAmerican MedicalsHRR2025-06-25
00194613096311MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613096342MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613115142MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00846338005634Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005641Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005658Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005665Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005672Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338002237Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338003111Bone CuretteELLIQUENCE, LLCHRR2025-01-09