FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
20757770469974
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
CX5984
Catalog number
CX5984
Device description
MILL LASER ENDO PROBE 20 ILLUM
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20757770469974PrimaryGS10
00757770469970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2075777046997420757770469974
00757770469970007577704699707577704699700757770469970

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification/vitrectomy systemAn assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014203Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014968Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014975Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014982Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031781EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031798EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031897Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
1081748902371320ga Curved Illuminated Laser Probe, 19ga Needle Illumination, IridexKATALYST SURGICAL LLCHQF2020-11-28
1081748902372020ga Curved Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-28
1081748902373720ga Curved Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-28
1081748902374420ga Curved Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-28
1081748902375120ga Curved Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-28
1081748902376823ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902377523ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902378223ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902379923ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902380523ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902381225ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902382925ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902383625ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902384325ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902385025ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-27
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27