FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770413140
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N2304
Catalog number
N2304
Device description
CHISEL BALLENGER 4MM
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
JYEChisel, Middle-Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYEChisel, Middle-EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770413140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770413140007577704131407577704131400757770413140

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear chiselA single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp and can be either straight or angled. It is typically a one-piece instrument made of high-grade stainless steel. 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
00757770405220Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770409693Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770417766Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770418695Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770424078Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770676439Bausch + LombBausch & Lomb IncorporatedJYE2025-08-05
00888515134157BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515228177BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229013BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229020BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229099BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230033BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230040BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230057BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230064BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
G586E7214220Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
G586E7214730Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
00190776319052MillenniumAvalign Technologies, Inc.JYE2023-06-23
00840343716868GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716875GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716882GEN2SURGIX MEDICAL LLCJYE2023-06-02
14026704805157PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
54026704805155PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
00840343700607Gen2SURGIX MEDICAL LLCJYE2022-10-18
00887482039755Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYE2022-09-28
G277G2E9009630Gen2SURGIX MEDICAL LLCJYE2022-09-23
00190660008796Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008802Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008550Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04
00190660008819Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04