FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
10757770059918
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SE5623B
Catalog number
SE5623B
Device description
23 ga. Bi-Blade Vitrectomy Cutter, 7500 cpm
Published
2019-11-15
Public version status
New
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
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
10757770059918PrimaryGS10
00757770059911Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075777005991810757770059918
00757770059911007577700599117577700599110757770059911

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
04251954900014Phaco Handpiece Sophi ECOThis AGHQE2026-02-11
10380650003291UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003307UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003314UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003611UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003628UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003635UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003666UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003673UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003680UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003772UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003789UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003796UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003802UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003840UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003857UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650004298UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004776UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004806UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004868UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004875UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005162UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005179UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005186UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005193UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007923UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007947UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008050UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008067UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008074UNITYAlcon Laboratories, Inc.HQE2025-04-08