FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770417766
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N1702 08
Catalog number
N1702 08
Device description
CLAMP OSSICLE HOLDING DERLACKI
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
JYFClamp, Ossicle Holding

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770417766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770417766007577704177667577704177660757770417766

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body extraction forcepsA hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. It is a rod with small jaws at its distal end which are controlled by pressing its handle; it may also include a magnifying lens and/or light source. This is a single-use 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
00757770413140Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770418695Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770424078Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770676439Bausch + LombBausch & Lomb IncorporatedJYE2025-08-05
00840183524562BR Surgical, LLCBR Surgical, LLCJYF2024-05-28
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
G586E7216220Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
G586E7216230Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
00190776318925MillenniumAvalign Technologies, Inc.JYF2023-06-23
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
14026704805621PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
54026704805629PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
54026704805155PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
00840343700607Gen2SURGIX MEDICAL LLCJYE2022-10-18