FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770415083
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N7759
Catalog number
N7759
Device description
ADAPTER ARNOLD
Published
2025-08-07
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
KAASet, Laryngeal Injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAASet, Laryngeal InjectionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770415083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770415083007577704150837577704150830757770415083

GMDN Terms#

Term, Definition table
TermDefinition
Vocal cord medialization implant injection needleA rigid, sharp, bevel-edged, hollow, tubular metal instrument intended to be used for injection of a vocal cord medialization implant, in gel form, into the vocal cord without direct visualization. It is typically curved to enable navigation of the pharynx; it is not intended to be used with an endoscope. This is a reusable device intended to be sterilized prior to use.

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
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
00757770429936Bausch + LombBausch & Lomb IncorporatedKAA2025-08-14
00757770420094Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770421541Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770428441Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770434756Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770436200Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00757770457861Bausch + LombBausch & Lomb IncorporatedKAA2025-08-07
00860009975156Endocraft LLCEndocraft, LLCKAA2023-07-06