FDA.reportPublic FDA data

Alcon

Primary DI
00380651295018
Brand
Alcon
Company
Alcon Laboratories, Inc.
Model
8065129501
Device description
Straight/Iris Bipolar Forceps
Published
2017-08-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQRApparatus, cautery, radiofrequency, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQRApparatus, Cautery, Radiofrequency, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380651295015PackageGS110In Commercial Distribution
00380651295018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065129501510380651295015
00380651295018003806512950183806512950180380651295018

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770636280Bausch + LombBausch & Lomb IncorporatedHQR2025-11-14
00757770430772Bausch + LombBausch & Lomb IncorporatedHQR2024-11-21
04049539100498DIATHERMY BIPOLAR CABLECarl Zeiss Meditec AGHQR2022-04-25
04049539100504DIATHERMY FORCEPSCarl Zeiss Meditec AGHQR2022-04-25
00757770423606Bausch + LombBausch & Lomb IncorporatedHQR2021-05-10
00781096115747Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115754Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115822Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115839Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115846Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115853Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115860Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115877Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115884Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115891Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115907Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115914Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115921Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115938Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115945Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115952Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115969Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115976Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096115983Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116003Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116010Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116027Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116034Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116041Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25
00781096116058Ducks UnlimitedMCGEE GROUP, INC., THEHQR2019-10-25