FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
20757770469943
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
CX5981
Catalog number
CX5981
Device description
MILL LASER ENDOPROBE 20 ANGLED
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
20757770469943PrimaryGS10
00757770469949Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2075777046994320757770469943
00757770469949007577704699497577704699490757770469949

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
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
10757770060464Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034683EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034690EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872032672EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032702EVA Custom TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032122EVA Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032139EVA Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032146EVA Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032153EVA Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032160EVA TDC Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032177EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032184EVA TDC Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032191EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032221EVA TDC Vitrectomy Pack Gravity Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032238EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872034430EVA NEXUS™, Phaco vitrectomy system including laser with DORC connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
08717872034447EVA NEXUS™, Phaco vitrectomy system including laser with SMA connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
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