FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
10757770524386
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
BL5234
Catalog number
BL5234
Device description
CHANDELIER ILL PROBE,23GA,5/BX
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
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K15160400023ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical , Ltd.2015-09-11MPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10757770524386PrimaryGS10
00757770524389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075777052438610757770524386
00757770524389007577705243897577705243890757770524389

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
5
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
00893872001653iTrack 250ENova Eye, Inc.MPA2026-05-05
00817325025010iChopperMEDIMAX TECH INC.MPA2026-04-30
00893872001684iTrack AdvanceNova Eye, Inc.MPA2026-04-15
00893872001660iLuminNova Eye, Inc.MPA2026-01-09
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCMPA2025-06-24
00840096215311XLEND25MULTIFLEXKATALYST SURGICAL LLCMPA2025-06-24
00810123483648Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-19
00810123483617Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
00810123483624Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
00810123483631Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
08717872035499TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
08717872035543TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
18717872035496TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
18717872035540TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
08717872035406Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
0871787203542023 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035444Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035451TotalView Endoillumination Probe, including illuminated scleral depressor.(23 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035468TotalView Endoillumination Probe, including illuminated scleral depressor.(25 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035475Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035482Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035505TotalView Endoillumination Probe, including illuminated scleral depressor.(20 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035512Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035529Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gaugeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035550Disposable Chandelier fiber (one fiber) with Photon connector and guidance needlD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035567Spaide TotalView Endoillumination Probe, including illuminated scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035581TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035598Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035403Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
1871787203542723 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31