THE BULLET, Alcon, INFINITECH

Primary DI
10380651092027
Brand
THE BULLET, Alcon, INFINITECH
Company
Alcon Laboratories, Inc.
Model
8065109202
Device description
The BULLET Shielded Endo Illuminator, Wide Angle Tip, 20Ga, 1.8m
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380651092027PackageGS110In Commercial Distribution
00380651092020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065109202710380651092027
00380651092020003806510920203806510920200380651092020

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length1.8Meter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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