FDA.reportPublic FDA data

FINESSE REFLEX

Primary DI
07612717071636
Brand
FINESSE REFLEX
Company
Alcon Laboratories, Inc.
Model
806.47
Device description
23G Serrated Forceps REFLEX DSP
Published
2022-06-22
Public version status
Update
Distribution status
Not 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
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17612717071633PackageGS16Not in Commercial Distribution
07612717071636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1761271707163317612717071633
07612717071636076127170716367612717071636

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, single-useA sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a single-use device.

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
00380658552060Clareon TruPlusREYWT8REYWT8.2802026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398668MillenniumAvalign Technologies, Inc.HNR2026-07-16
00190776398699MillenniumAvalign Technologies, Inc.HNR2026-07-16
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
05060411983007Capsulorhexis Forceps, Utrata Tips, 12mm Curved Shafts, Round HandlesDTR MEDICAL LIMITEDHNR2026-06-10
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D502002S0STORZ Utrata Capsulorhexis ForcepsDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5011895020COLIBRI FORCEP 0.4 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5019300STORZ CASTROVEIJO COLIBRI FORCEPS 0.12DAUD JEE MFG. COHNR2022-12-13
G006D5023500HOFFER-MCPHERSON FORCEPS DEL 11M LONG JAWSDAUD JEE MFG. COHNR2022-12-13
G006D5025000CASTROVIEJO FORCEPS 0.12MM DAUD JEE MFG. COHNR2022-12-13
G006D5025100CASTROVIEJO FORCEPS 0.3MM DAUD JEE MFG. COHNR2022-12-13
G006D5025200CASTROVIEJO FORCEPS 0.5MM DAUD JEE MFG. COHNR2022-12-13
G006D5025300CASTROVIEJO FORCEPS 0.9MM DAUD JEE MFG. COHNR2022-12-13
G006D50253000CASTROVIEJO FORCEPS 0.12MM DAUD JEE MFG. COHNR2022-12-13
G006D502530010CASTROVIEJO FORCEPS 0.3MM DAUD JEE MFG. COHNR2022-12-13
G006D502530020CASTROVIEJO FORCEPS 0.5MM DAUD JEE MFG. COHNR2022-12-13
G006D5023000MCPHERSON FORCEPS 1X2 STR DAUD JEE MFG. COHNR2022-12-12
G006D5023100MCPHERSON FORCEPS 1X2 ANG DAUD JEE MFG. COHNR2022-12-12
G006D5023300KELMAN-MCPHERSON FORCEPS 8MM LONG JAWS, 0.3MMDAUD JEE MFG. COHNR2022-12-12
G006D5011895030COLIBRI FORCEP 0.12 W/TYING PLATFORM OBLIQUEDAUD JEE MFG. COHNR2022-12-10
G006D50131600French M patern Corneal forceps, delicate, 1x2 , 0.12DAUD JEE MFG. COHNR2022-12-10