FDA.reportPublic FDA data

SINSKEY IOL HOOK 12/BOX

Primary DI
24058935005126
Brand
SINSKEY IOL HOOK 12/BOX
Company
Bausch & Lomb GmbH
Model
SUF02
Catalog number
SUF02
Device description
Single Use Medical Device for Ophthalmic Surgery
Published
2023-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058935005122PrimaryGS10
24058935005126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058935005122040589350051224058935005122
2405893500512624058935005126

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344609518
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00757770688548Bausch + LombBausch & Lomb IncorporatedHND2026-05-11
00190776420994MillenniumAvalign Technologies, Inc.HND2026-04-30
00757770501229Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770505753Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511006Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511020Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511037Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511075Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770520138Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770522682Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
G346EP02SSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346P1607SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346EC34Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-20
G346EP1850Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-02
G346EP44900Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-01
00841668144398KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144404KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144428KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144435KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144442KatenaKATENA PRODUCTS, INC.HND2026-03-31
05056785303350Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
05056785303336Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
G346EP203L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP203R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP204L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP204R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
05056785302636Connor Wand - StraightBLINK MEDICAL LIMITEDHND2025-11-05
04058935012939Spatula Phaco KochBausch & Lomb GmbHHND2025-10-26
04058935012953Spatula JohnsonBausch & Lomb GmbHHND2025-10-26
04058935012779Fogla Trifacet SpatulaBausch & Lomb GmbHHND2025-10-24