FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770420322
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N6065 2
Catalog number
N6065 2
Device description
BLD F/N6050,055,060 & 070 MED
Published
2025-07-29
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
KBHAdenotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBHAdenotomeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770420322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770420322007577704203227577704203220757770420322

GMDN Terms#

Term, Definition table
TermDefinition
Sharps crusherA mains electricity (AC-powered) device designed to crush and destroy used sharps (e.g., needles and syringes, cannulae, scalpel blades) to render them unusable and safe for further handling.

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
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
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770424443Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770429974Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00757770430055Bausch + LombBausch & Lomb IncorporatedKBH2025-07-29
00190776381943MillenniumAvalign Technologies, Inc.KBH2024-04-30
G586E8221210Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221220Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221230Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221240Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221720Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221730Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
G586E8221740Novo SurgicalNOVO SURGICAL, INC.KBH2023-12-18
00190776352721MillenniumAvalign Technologies, Inc.KBH2023-11-17
00190776049430AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776227999AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228002AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776228019AvalignAvalign Technologies, Inc.KBH2023-09-28
00190776327194MillenniumAvalign Technologies, Inc.KBH2023-06-23
G22313594910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKBH2023-06-08
00887482192825Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00887482192832Symmetry ASPEN SURGICAL PRODUCTS, INC.KBH2022-12-08
00842331170294Novo Surgical Inc. NOVO SURGICAL, INC.KBH2022-11-13
00190660000103Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000110Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000127Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000134Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000141Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000158Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000165Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000172Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04
00190660000189Ambler SurgicalAMBLER SURGICAL CORP.KBH2021-01-04