FDA.reportPublic FDA data

FINESSE REFLEX

Primary DI
17612717071732
Brand
FINESSE REFLEX
Company
Alcon Laboratories, Inc.
Model
811.53
Device description
27+ Straight Scissors REFLEX DSP
Published
2024-06-27
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
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17612717071732PackageGS16In Commercial Distribution
07612717071735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1761271707173217612717071732
07612717071735076127170717357612717071735

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, probe-like, single-useA sterile, hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). As a complete instrument it comprises two shearing blades at the end of a probe-/cannula-like shaft with a proximal slimline handle, typically operated by squeezing. It is available with various blade designs and sizes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge

Sterilization Methods#

Method table
Method

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
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
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060480407480Scissors EnucleationBLINK MEDICAL LIMITEDHNF2026-09-25
00840319759431Hayden MedicalHayden Medical, Inc.HNF2026-09-04
00190776419103MillenniumAvalign Technologies, Inc.HNF2026-08-23
B382SD9037751020Surgical DirectSurgical Direct, Inc.HNF2026-08-07
G22312349490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2026-08-03
00190776422431MillenniumAvalign Technologies, Inc.HNF2026-07-31
00192896123564Castroviejo Corneal ScissorsSONTEC INSTRUMENTS, INC.HNF2026-07-27
00190776405816MillenniumAvalign Technologies, Inc.HNF2026-07-26
00190776421892MillenniumAvalign Technologies, Inc.HNF2026-07-23
00190776403904MillenniumAvalign Technologies, Inc.HNF2026-07-22
00190776397135MillenniumAvalign Technologies, Inc.HNF2026-07-16
04059453161574Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-06-03
04251047920554Vannas Capsulotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047921278Metzenbaum ScissorsA1 Medical GmbHHNF2026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936395Vitrectomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936432Gerten Iridectomy ScissorA1 Medical GmbHHNF2026-05-29
G346EA4018GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-04-23
G2231349550Ophthalmic ScissorsMedetz Surgical Instruments LLCHNF2026-04-09
09348811004192INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
09348811004260INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
G346EA40SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-10-29
G346EA0823GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-09-29
07612717071643FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071704FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071735FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
08052276028358Retinal Tip 23G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028372Retinal Tip 25G Microscissors CurvedAKTIVE SRLHNF2024-01-15