FDA.reportPublic FDA data

27ga Maeno-Awh Super Manipulator

Primary DI
10817489027285
Brand
27ga Maeno-Awh Super Manipulator
Company
KATALYST SURGICAL LLC
Model
DV1030-27
Device description
27ga Maeno-Awh Super Manipulator
Published
2018-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10817489027285PrimaryGS10
00817489027288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902728510817489027285
00817489027288008174890272888174890272880817489027288

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007883297
Device count
5
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840516120775Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120782Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120799Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120805Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120812Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120829Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120836Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120843Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120850Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30
00840516120867Anodyne SurgicalPsi/Eye-Ko, Inc.MXY2023-08-30