FDA.reportPublic FDA data

Viscous Fluid Cannula

Primary DI
00853480006167
Brand
Viscous Fluid Cannula
Company
ESCALON MEDICAL CORP.
Model
9849-51
Catalog number
TR9849-51
Device description
A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the posterior chamber of the eye, and is particularly designed for use with high-viscosity fluids. The flanged cannula is designed to easily suture into place and is qualified for use at operating pressures of up to 70 psi. Sterile, Single Use
Published
2016-01-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853480006164PackageGS13In Commercial Distribution
00853480006167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085348000616410853480006164
00853480006167008534800061678534800061670853480006167

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-486-4848info@escalonmed.com

Regulatory Flags#

DUNS number
879144426
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853480006020Fiber Optic Light GuideStandard, 20 ga, UniversalTR9800-112016-01-14
10853480006027Fiber Optic Light GuideStandard, 20 ga, UniversalTR9800-112016-01-14
00853480006037Fiber Optic Light GuideStandard, 20 ga, TREK/GreishaberTR9800-612016-01-14
00853480006044Fiber Optic Light Guide45°, 20 ga, UniversalTR9801-112016-01-14
00853480006051Fiber Optic Light Guide45°, 20 ga, TREK/GreishaberTR9801-612016-01-14
00853480006068Fiber Optic Light Guide45°Retinal Knife, UniversalTR9806-112016-01-14
00853480006075Fiber Optic Light Guide45° Retinal Knife, TREK/GreishaberTR9806-612016-01-14
00853480006082Fiber Optic Light GuideWide Angle, 20 ga, UniversalTR9821-112016-01-14
00853480006099Fiber Optic Light GuideWide Angle, 20 ga, TREK/GreishablerTR9821-612016-01-14
00853480006105Fiber Optic Light GuideSiepser ShieldedTR9879-112016-01-14
00853480006112Fiber Optic Light GuideDCR, 20 gaTR9880-112016-01-14
10853480006034Fiber Optic Light GuideStandard, 20 ga, TREK/GreishaberTR9800-612016-01-14
10853480006041Fiber Optic Light Guide45°, 20 ga, UniversalTR9801-112016-01-14
10853480006058Fiber Optic Light Guide45°, 20 ga, TREK/GreishaberTR9801-612016-01-14
10853480006065Fiber Optic Light Guide45°Retinal Knife, UniversalTR9806-112016-01-14
10853480006072Fiber Optic Light Guide45° Retinal Knife, TREK/GreishaberTR9806-612016-01-14
10853480006089Fiber Optic Light GuideWide Angle, 20 ga, UniversalTR9821-112016-01-14
10853480006096Fiber Optic Light GuideWide Angle, 20 ga, TREK/GreishablerTR9821-612016-01-14
10853480006102Fiber Optic Light GuideSiepser ShieldedTR9879-112016-01-14
10853480006119Fiber Optic Light GuideDCR, 20 gaTR9880-112016-01-14

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