FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770405664
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N7700 1
Catalog number
N7700 1
Device description
LARYN MIR W/HDL SZ1
Published
2025-07-28
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
00757770405664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770405664007577704056647577704056640757770405664

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
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
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
00757770426027Bausch + LombBausch & Lomb IncorporatedKAI2026-04-30
00757770457601Bausch + LombBausch & Lomb IncorporatedKAI2026-04-30
00190776420017MillenniumAvalign Technologies, Inc.KAI2026-04-15
00190776419165MillenniumAvalign Technologies, Inc.KAI2026-04-13
00190776417642MillenniumAvalign Technologies, Inc.KAI2026-03-04
00190776415709MillenniumAvalign Technologies, Inc.KAI2026-02-04
09348811109620INKAThe Trustee for KAISER FAMILY TRUSTKAI2025-11-25
00190776413286MillenniumAvalign Technologies, Inc.KAI2025-10-09
04250676710079Atticus mirrorSpiggle & Theis Medizintechnik GmbHKAI2025-09-25
04250676718006Mirror, round, polishedSpiggle & Theis Medizintechnik GmbHKAI2025-09-19
00194613011741MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011758MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011772MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011789MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011802MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011826MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011833MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613043865MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613044589MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049416MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049423MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049430MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049454MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049485MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049492MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049515MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613103385MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00757770402847Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28
00757770409273Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28
00757770410477Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28