FDA.reportPublic FDA data

Straight Forceps, Bayonet Handle, .3mm 1x2 teeth, 210mm Kogent

Primary DI
00840096212297
Brand
Straight Forceps, Bayonet Handle, .3mm 1x2 teeth, 210mm Kogent
Company
KATALYST SURGICAL LLC
Model
N3204-K
Device description
Each, Dissection Forceps, 210mm
Published
2020-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096212297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096212297008400962122978400962122970840096212297

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

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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
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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

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