FDA.reportPublic FDA data

Angled Cystotome

Primary DI
00813465010527
Brand
Angled Cystotome
Company
HURRICANE MEDICAL INC
Model
3427
Catalog number
3427
Device description
Creates opening into anterior capsule during cataract treatment.
Published
2020-01-23
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813465010527PrimaryGS10
10813465010524Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813465010527008134650105278134650105270813465010527
1081346501052410813465010524

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge27Gauge

Sterilization Methods#

Method table
Method
Radiation Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
093377724
Device count
1
DM exempt
true
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813465011132IOL Manipulator - Lester680168012020-05-08
10813465011149IOL Manipulator - Sinskey680268022020-05-08
10813465011163IOL Manipulator - Sinskey680468042020-05-08
10813465011170Nucleus Chopper - P. Koch681068102020-05-08
10813465011187Nucleus Chopper - Beckingsale681168112020-05-08
10813465011194Silicone Tubing700270022020-05-07
10813465011316Marker Pad - Gentian Violet730373032020-05-07
10813465011323Marker Pad - Methylene Blue730473042020-05-07
10813465011439Dual Tip Marker Pen - Gentian Violet731973192020-05-07
10813465011446Dual Tip Marker Pen - Methylene Blue732073202020-05-07
10813465012122.20 Micron Filter930193012020-05-07
10813465012146Male to Male Luer Connector930393032020-05-07
10813465011354LASIK Incise Film730973092020-05-05
10813465011422LASIK Incise Tape731873182020-05-05
10813465012078Surgical Glide920192012020-05-05
10813465012108IOL Glide - Sheets920492042020-05-05
10813465012153Clear Eye Shield - Non-sterile940194012020-05-05
10813465012160Clear Eye Shield940294022020-05-05
10813465012191Incise Film970197012020-05-05
10813465010982Replacement Tubing552455242020-05-04

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