FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
10757770059840
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
BL5625S
Catalog number
BL5625S
Device description
25 ga Stellaris PC Vitrectomy Probe
Published
2018-08-02
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
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770059840PrimaryGS10
00757770059843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075777005984010757770059840
00757770059843007577700598437577700598430757770059843

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy systemAn assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric, pneumatic) through a dedicated hand-held instrument, which converts the energy into an oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This system will typically consist of a generator to provide the energy, an infusion and suction system to supply replacement fluid and remove debris, a cutting handpiece and cables, and a foot control. This assembly is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055210449Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210456Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210463Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210869Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210876Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210883Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055243294Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410236SOPHI AThis AGHQC2026-02-11
07640179410755Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410779Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410793Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
07640179410007SOPHIThis AGHQC2026-02-10
07640179410090SOPHIThis AGHQC2026-02-10
07630003909104Oertli®Oertli-Instrumente AGHQC2025-12-19
07630003910339Oertli®Oertli-Instrumente AGHQC2025-12-19
00380650002976UNITYAlcon Laboratories, Inc.HQC2025-11-18
07630003920178Oertli®Oertli-Instrumente AGHQC2025-09-19
00850005541080MICOR Auto I/ACarl Zeiss Meditec, Cataract Technology, Inc.HQC2025-08-19
00757770684571Bausch + LombBausch & Lomb IncorporatedHQC2025-07-18
10380650003208UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003215UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003222UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003239UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003352UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003369UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003376UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003383UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003437UNITYAlcon Laboratories, Inc.HQC2025-04-07
00380650003447UNITYAlcon Laboratories, Inc.HQC2025-04-07