FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770469475
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N1451
Catalog number
N1451
Device description
RONGEUR LEMPERT STAINLESS
Published
2025-07-30
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
KBBRongeur, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770469475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770469475007577704694757577704694750757770469475

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770409167Bausch + LombS2050 10SS2050 10S2016-09-24
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462905768evonosevonos GmbH & Co. KGKBB2026-08-21
04054462910915evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910922evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910939evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910953evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910960evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911011evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911028evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911035evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911042evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911059evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911066evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911073evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911080evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911097evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911103evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911110evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911127evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911134evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911141evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911158evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911165evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911172evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911189evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911196evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911202evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911219evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911226evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911233evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911257evonosevonos GmbH & Co. KGKBB2026-08-19