FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
20757770469936
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
CX5980
Catalog number
CX5980
Device description
MILL LASER ENDOPROBE 20 TAPER
Published
2016-09-24
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
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20757770469936PrimaryGS10
00757770469932Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2075777046993620757770469936
00757770469932007577704699327577704699320757770469932

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

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Primary DI, Brand, Company table
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03830074980017MR Q Meridian Medical d.o.o.HQF2025-10-20
03830074980024MR Q SLTMeridian Medical d.o.o.HQF2025-10-20
03830074980048Merilas Meridian Medical d.o.o.HQF2025-10-20
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.HQF2025-08-11
07290018686058Voyager DSLTBELKIN VISION LTDHQF2025-07-16
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.HQF2025-07-08
03700542625958CAPSULOQUANTEL MEDICALHQF2025-03-25
05700002165466Norlase LYNX photocoagulatorNorlase ApSHQF2024-10-30
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00813125010195Eye Safety Filter, Fixed (810 nm)IRIDEX CORPORATIONHQF2024-10-21
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00813125017125Eye Safety Filter, Fixed (810 nm) IRIDEX CORPORATIONHQF2024-10-21
00813125017132Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATIONHQF2024-10-21
00813125017156Eye Safety Filter, Fixed (532 nm)IRIDEX CORPORATIONHQF2024-10-21
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