FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
20757770056792
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
DP8245S
Catalog number
DP8245S
Device description
Needles Microflow 45 Degree
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
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20757770056792PrimaryGS10
00757770056798Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2075777005679220757770056792
00757770056798007577700567987577700567980757770056798

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification system handpiece tip, single-useA device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
6
Kit
true
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
10757770060464Bausch + LombBausch & Lomb IncorporatedHQC2026-04-09
07630055210319Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210326Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210333Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210807Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210814Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210821Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055252883HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055253293Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410762Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410786Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410809Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
08717872035390Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035413TotalView Endoillumination Probe, including illuminated scleral depressor.(27 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035437Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
0871787203553627G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872035604Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036595Disposable EVA DrapesD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
08717872036601Disposable EVA VGPC Input SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2025-03-31
07630003915709Oertli®Oertli-Instrumente AGHQC2024-10-15
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034683EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034690EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034744EVA NEXUS™ Combined 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034768EVA NEXUS™ Combined 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20
08717872034782EVA NEXUS™ Combined 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQC2024-02-20