FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770426027
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N77101
Catalog number
N77101
Device description
LARYN MIR W/O HDL SZ1
Published
2026-04-30
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
KAIMirror, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770426027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770426027007577704260277577704260270757770426027

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. 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
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
04054462902880evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902910evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902934evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902941evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902958evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902965evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902972evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902989evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902996evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903061evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903078evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903085evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902767evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902774evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902781evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902798evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902804evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902811evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902828evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902835evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902842evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902859evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902866evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902873evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902897evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902903evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902927evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903009evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903016evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903023evonosevonos GmbH & Co. KGKAI2026-08-18