FDA.report

Titanium Straight Castroviejo Suturing Forceps, 0.3mm Teeth, 108mm

Primary DI
00817489028889
Brand
Titanium Straight Castroviejo Suturing Forceps, 0.3mm Teeth, 108mm
Company
KATALYST SURGICAL LLC
Model
3601S-30-108
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817489028889PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
007883297
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840096207606DEX TIPS™ Universal HandleCV-Handle2020-06-08
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorXLCYCLO2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorXLCYCLOA2018-12-11
10817489024536Revolver FiberV66002019-07-17
10817489024833Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5DKIF7-05S2017-03-22
10817489024840Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5DKIF7-10S2017-03-22
10817489024857Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5DKIF7-15S2017-03-22
10817489024864Disposable Bipolar Focused Irrigating Forceps, 8", 0.5mm Straight Tips, Box of 5DKIF8-05S2017-03-22
10817489024871Disposable Bipolar Focused Irrigating Forceps, 8", 1.0mm Straight Tips, Box of 5DKIF8-10S2017-03-22
10817489024888Disposable Bipolar Focused Irrigating Forceps, 8", 1.5mm Straight Tips, Box of 5DKIF8-15S2017-03-22
10817489024895Disposable Bipolar Focused Irrigating Forceps, 9", 0.5mm Straight Tips, Box of 5DKIF9-05S2017-03-22
10817489024901Disposable Bipolar Focused Irrigating Forceps, 9", 1.0mm Straight Tips, Box of 5DKIF9-10S2017-03-22
10817489024918Disposable Bipolar Focused Irrigating Forceps, 9", 1.5mm Straight Tips, Box of 5DKIF9-15S2017-03-22
1081748902557120ga Focal Light PipeV2000-20V2017-10-13
1081748902558823ga Focal Light PipeV2000-23R2017-10-13
1081748902559523ga Focal Light PipeV2000-23V2017-10-13
1081748902560125ga Focal Light Pipe V2000-25R2017-10-13
1081748902561825ga Focal Light Pipe V2000-25V2017-10-13
1081748902562527ga Focal Light PipeV2000-27R2017-10-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704941661PILLINGTELEFLEX INCORPORATEDHNR2026-03-23
G346EA0323SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-03-12
00840319758854Hayden MedicalHayden Medical, Inc.HNR2026-03-06
00190776417659MillenniumAvalign Technologies, Inc.HNR2026-03-04
74546951616426MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951616433MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951616440MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951619090MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951619106MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635595MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635601MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635618MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635625MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635632MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635649MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635656MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635663MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635670MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635687MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635694MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635700MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635717MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635724MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635731MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635748MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635755MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635762MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635779MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635786MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635793MANI MICRO FORCEPSMANI, INC.HNR2026-03-03