FDA.reportPublic FDA data

Belz Lacrimal Sac Rongeur

Primary DI
04058935012762
Brand
Belz Lacrimal Sac Rongeur
Company
Bausch & Lomb GmbH
Model
E4590
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNGRongeur, Lachrymal Sac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNGRongeur, Lachrymal SacOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058935012762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058935012762040589350127624058935012762

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
344609518
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058935012779Fogla Trifacet SpatulaE04792025-10-24
04058935012786Fogla Pointed DissectorE04802025-10-24
04058935012809Guide ClaymanE05422025-10-24
04058935012816Hook Lens And Iris SinskeyE05452025-10-24
04058935012823Hook Lens OgawaE05692025-10-24
04058935012830Chopper Spatula NichaminE0570 N2025-10-24
04058935012847Hook Lens Manipulator LesterE05712025-10-24
04058935012854Hook Lens Insertion FenzlE05722025-10-24
04058935012861Chopper Phaco Left NagaharaE0578 L2025-10-25
04058935012878Chopper Phaco Right NagaharaE0578 R2025-10-26
04058935012885Hook Lens MaloneyE05792025-10-26
04058935012892Chopper Ambidextrous SeibelE05902025-10-26
04058935012908Hook Muscle StevensE06002025-10-26
04058935012915Manipulator Nucleus DrysdaleE06292025-10-26
04058935012922Brody Multipurpose ManipulatorE06362025-10-26
04058935012939Spatula Phaco KochE07122025-10-26
04058935012946Snapper Lens ChopperE07292025-10-26
04058935012953Spatula JohnsonE07302025-10-26
04058935012960Chopper Quick-Chop Braga MeleE07562025-10-26
04058935012977Forceps Fixation Curved MoodyE15532025-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770404476Bausch + LombBausch & Lomb IncorporatedHNG2024-11-20
00850048576063Intacs Pocketing HookADDITION TECHNOLOGY, INC.HNG2023-06-13
00810799035554Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035561Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035578Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035585Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00810799035592Stephens InstrumentsKRISHNA IMPORTS INCHNG2020-09-22
00841668108475RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108482RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108499RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108505RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108512RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00841668108529RongeurKATENA PRODUCTS, INC.HNG2020-09-14
00840159903339RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01
00840159907856RumexRUMEX INTERNATIONAL CORP.HNG2020-06-01