FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770433667
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N0314
Catalog number
N0314
Device description
DIAG HD STORZ-BRUENING MAG
Published
2025-10-13
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
HOISpectacle, Magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770433667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770433667007577704336677577704336670757770433667

GMDN Terms#

Term, Definition table
TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. 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
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
00628120772388AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772395AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772425AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772753AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772791AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772814AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772821AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772838AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772852AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772869AYA OpticalClaudia Alan IncHOI2025-01-18
00628120772890AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773583AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773590AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773620AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773835AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773842AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773859AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773873AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773880AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773903AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773910AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773927AYA OpticalClaudia Alan IncHOI2025-01-18
00628120773934AYA OpticalClaudia Alan IncHOI2025-01-18
07640288790618read onRead On Inc.HOI2023-12-08
07640288790625read onRead On Inc.HOI2023-12-08
07640288790632read onRead On Inc.HOI2023-12-05
07640288790649read onRead On Inc.HOI2023-12-05
07640288790656read onRead On Inc.HOI2023-12-05
07640288790663read onRead On Inc.HOI2023-12-05
07640288790670read onRead On Inc.HOI2023-12-05