FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
20757770482621
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
CX6805
Catalog number
CX6805
Device description
25 GA PNEUMATIC HSV CUTTER
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
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20757770482621PrimaryGS10
00757770482627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2075777048262120757770482621
00757770482627007577704826277577704826270757770482627

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system micro-cutting unitA sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.

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 IncorporatedHQE2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
00380650003294UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003300UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003317UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003614UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003621UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003638UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003669UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003676UNITYAlcon Laboratories, Inc.HQE2025-04-08
0871787203654027G Two Dimensional Cutter – 20k CPMD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-04-01
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
00380650003324UNITYAlcon Laboratories, Inc.HQE2024-11-19
00380650003348UNITYAlcon Laboratories, Inc.HQE2024-11-19
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-09-27
00380650001252UNITYAlcon Laboratories, Inc.HQE2024-07-02
08717872035109EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035116EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035123EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035307EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035314EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035321EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035338EVA NEXUS™ Combined 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21