FDA.reportPublic FDA data

Titanium Nucleus Fragment Forceps, 110mm

Primary DI
00817489028643
Brand
Titanium Nucleus Fragment Forceps, 110mm
Company
KATALYST SURGICAL LLC
Model
3510-110
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00817489028643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817489028643008174890286438174890286430817489028643

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. 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
10817489027483Laser Probe OS4, MultiFlex, 23gaVK4003032019-03-19
10817489027490Laser Probe OS4, MultiFlex, 25gaVK4003052019-03-19
10817489027506Laser Probe OS4, MultiFlex Inverted, 23gaVK4003132019-03-19
10817489027513Laser Probe OS4, MultiFlex Inverted, 25gaVK4003152019-03-19
10817489027520Laser Probe OS4, MultiFlex Extendable, 23gaVK4003232019-03-19
10817489027544Laser Probe OS4, MultiFlex Inverted Extendable, 23gaVK4003332019-03-19
10817489027551Laser Probe OS4, MultiFlex Inverted Extendable, 25gaVK4003352019-03-19
1084009621123520ga Straight Laser Probe6202002020-03-04
1084009621124223ga Straight Laser Probe6202012020-03-04
1084009621125925ga Straight Laser Probe6202022020-03-04
1084009621126627ga Straight Laser Probe6202032020-03-04
1084009621127323ga Flexible Curved Laser Probe6202102020-03-04
1084009621128025ga Flexible Curved Laser Probe6202112020-03-04
1084009621129727ga Flexible Curved Laser Probe6202122020-03-04
1084009621130320ga Illuminated Straight Laser Probe6202202020-03-04
1084009621131023ga Illuminated Straight Laser Probe6202212020-03-04
1084009621132725ga Illuminated Straight Laser Probe6202222020-03-04
1084009621133427ga Illuminated Straight Laser Probe6202232020-03-04
1084009621134123ga Illuminated Flexible Curved Laser Probe6202292020-03-04
1084009621135825ga Illuminated Flexible Curved Laser Probe6202302020-03-04

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
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
G006D5015660HOFMANN-POLACK SUTURING FORCEPS 0.2MMDAUD JEE MFG. COHNR2022-12-10