FDA.reportPublic FDA data

Titanium Westcott Curved Tenotomy Scissors, Blunt Tips, Stainless Steel

Primary DI
00840096202557
Brand
Titanium Westcott Curved Tenotomy Scissors, Blunt Tips, Stainless Steel
Company
KATALYST SURGICAL LLC
Model
6601C-110SS
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00840096202557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096202557008400962025578400962025570840096202557

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081748902202325ga Dex™ Serrated Jaw ForcepsDVF4016-252016-08-11
0081748902214625ga Dex™ Maculorhexis ForcepsDVF4019-252016-08-11
00840096207606DEX TIPS™ Universal HandleCV-Handle2020-06-08
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10840096211365Cili Probes (Cyclophotocoagulation)6202312020-03-04
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorXLCYCLO2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorXLCYCLOA2018-12-11
10817489025151Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700A2017-07-21
10817489025168Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700C2017-07-21
1084009621532527ga Stiff Slim DEX™ NanoTapered™ Awh ForcepsDVFO4005-272025-10-06
00840096214987Curved Up Micro Scissors, 11mm Blades, Bayonet Round Handle, 230mmN61062025-09-10
1081748902356020ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-20AR2020-11-25
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-20BR2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-20CR2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-20ER2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCV6300-20JR2020-11-27
1081748902361423ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-23AR2020-11-25
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-23BR2020-11-27
1081748902363823ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-23CR2020-11-27
1081748902364523ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-23ER2020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08052276028464Retinal Tip vertical 20GAKTIVE SRLHNF2024-01-15
08052276028488Retinal Tip vertical 23GAKTIVE SRLHNF2024-01-15
08052276028501Retinal Tip vertical 25GAKTIVE SRLHNF2024-01-15
0805227602804455° Rotary microscissor 20G only Tip AKTIVE SRLHNF2024-01-11
08052276028129Retinal Tip 20G Microscissors CurvedAKTIVE SRLHNF2024-01-11
08052276028143Retinal Tip 20G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028310Retinal Tip 23G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028334Retinal Tip 25G Microscissors StraightAKTIVE SRLHNF2024-01-11
08175700144605Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700144612Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145206Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145213Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145220Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145237Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145244Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145602Iris ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08052276028136TWEEZER CUT CURVED 20GAKTIVE SRLHNF2023-06-13
08052276028150TWEEZER CUT STRAIGHT 20GAKTIVE SRLHNF2023-06-13
08052276028327TWEEZER CUT STRAIGHT 23GAKTIVE SRLHNF2023-06-13