FDA.reportPublic FDA data

27ga Holekamp Drip Dropper™, Soft Tip, Fluted

Primary DI
10817489026226
Brand
27ga Holekamp Drip Dropper™, Soft Tip, Fluted
Company
KATALYST SURGICAL LLC
Model
DV1200-27F
Device description
Box of 5, 27ga Holekamp Drip Dropper™, Soft Tip, Fluted
Published
2020-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MXYCannula,Ophthalmic,Posterior Capsular Polishing,Polyvinyl Acetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817489026226PrimaryGS10
00817489026229Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902622610817489026226
00817489026229008174890262298174890262290817489026229

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). 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
04251047923630Kratz Capsule PolisherA1 Medical GmbHMXY2026-05-29
00757770701216Bausch + LombBausch & Lomb IncorporatedMXY2025-11-16
00757770701223Bausch + LombBausch & Lomb IncorporatedMXY2025-11-16
00757770446995Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00757770494156Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00757770505746Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00757770505845Bausch + LombBausch & Lomb IncorporatedMXY2025-08-07
00194613002541MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613002558MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613002572MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613002602MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613003067MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613083908MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00194613105488MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-08-01
00757770509188Bausch + LombBausch & Lomb IncorporatedMXY2025-07-29
00757770510672Bausch + LombBausch & Lomb IncorporatedMXY2025-07-29
00194613002596MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-03-21
00194613002633MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-03-21
00194613003081MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2025-03-21
00194613018290MSI Precision Specialty InstrumentsMed Saver, Inc.MXY2024-08-15
G223119400D0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCMXY2023-09-25
00840516116907Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116914Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116921Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116938Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116945Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116952Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116969Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116976Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516116983Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30