FDA.report

Anterior Chamber Maintainer

Primary DI
00813465010343
Brand
Anterior Chamber Maintainer
Company
HURRICANE MEDICAL INC
Model
2520
Catalog number
2520
Device description
Irrigation
Published
2020-01-21
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
false

Related Records

Product Codes

CodeName
HMXCannula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813465010343PrimaryGS10
10813465010340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813465010343008134650103438134650103430813465010343
1081346501034010813465010340

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA 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. 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 reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Needle Gauge20Gauge

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Ethylene Oxide;Radiation Sterilization

Regulatory Flags

DUNS number
093377724
Device count
5
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

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10813465011439Dual Tip Marker Pen - Gentian Violet731973192020-05-07
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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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