FDA.reportPublic FDA data

25ga DEX™ Yamane IOL Fixation Forceps

Primary DI
10840096211556
Brand
25ga DEX™ Yamane IOL Fixation Forceps
Company
KATALYST SURGICAL LLC
Model
DVF4032-25
Device description
25ga DEX™ Yamane IOL Fixation Forceps
Published
2020-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNKProbe, Trabeculotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNKProbe, TrabeculotomyOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840096211556PrimaryGS10
00840096211559Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084009621155610840096211556
00840096211559008400962115598400962115590840096211559

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, single-useA sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a single-use device.

Regulatory Flags#

DUNS number
007883297
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsDNK8-15SDNK8-15S2026-10-08
0081748902541323ga DEX™ Morris ILM ForcepsDVF4033-23DVF4033-232026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsDVF4036-27DVF4036-272026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsDVF4036-23DVF4036-232026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsDVF4036-25DVF4036-252026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsDVF4005-25-SDVF4005-25-S2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsDVF4010-25-SDVF4010-25-S2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsDVF4014-25-SDVF4014-25-S2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsDVF4016-25-SDVF4016-25-S2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsDVF4019-25-SDVF4019-25-S2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsDVF4022-25-SDVF4022-25-S2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsDVF4033-25-SDVF4033-25-S2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsDVF4034-25-SDVF4034-25-S2026-10-07
0084009620518325ga DEX Stiff Curved Horizontal ScissorsDVS5006-25-SDVS5006-25-S2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsDVS5101-25-SDVS5101-25-S2026-10-07
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsDNK7-05SDNK7-05S2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsDNK7-10SDNK7-10S2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsDNK7-15SDNK7-15S2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsDNK8-05SDNK8-05S2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsDNK8-10SDNK8-10S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776419721MillenniumAvalign Technologies, Inc.HNK2026-08-25
04547451338628Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451338635Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451338642Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451336808Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-13
00840306824036Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
00840306824043Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
00840306824050Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
04547451338062Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2024-10-07
00840343723910GEN2SURGIX MEDICAL LLCHNK2024-09-19
00887482049280Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNK2024-08-20
G586OP7135320Novo SurgicalNOVO SURGICAL, INC.HNK2023-12-18
G586OP7135330Novo SurgicalNOVO SURGICAL, INC.HNK2023-12-18
04547451332381Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451332398Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451332404Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335337Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335344Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335351Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
00190776359508MillenniumAvalign Technologies, Inc.HNK2023-02-22
00841668128022HARMS TRABECULOTOMY PROBE RIGHTKATENA PRODUCTS, INC.HNK2022-12-07
00841668128039HARMS TRABECULOTOMY PROBE LEFTKATENA PRODUCTS, INC.HNK2022-12-07
04049368055662N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055693N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055938N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055952N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368144908N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368144915N.A.Geuder AktiengesellschaftHNK2021-07-05
00190660127343Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
00190660127350Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04