FDA.reportPublic FDA data

Viscous Fluid Pack

Primary DI
00853480006013
Brand
Viscous Fluid Pack
Company
ESCALON MEDICAL CORP.
Model
8170-11
Catalog number
TR8170-11
Device description
Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Sonomed Escalon Viscous Fluid System, Trek VFI-10, Richard James FTS-50 and FTS-100 systems, Greishaber VIS, and others. Pack includes 10cc syringe with pressure-tested tubing and adapters, stainless steel cannula, and Teflon cannula. 0.2 micron filter included to maintain sterile field. 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
MRHPump, Infusion, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRHPump, Infusion, OphthalmicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963434000VISCOUS FLUID SYSTEMEscalon Trek Medical1996-11-25MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853480006010PackageGS110In Commercial Distribution
00853480006013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085348000601010853480006010
00853480006013008534800060138534800060130853480006013

GMDN Terms#

Term, Definition table
TermDefinition
Eye-surface lavage systemA device assembly designed for automated or semi-automated irrigation and washing of the eye surface (i.e., sclera and cornea). It typically consists of a main electromechanical unit that may include a pump for infusion of non-medicated liquid (e.g., saline), an extractor, and controls for the temperature and the rate of irrigation; it may be coupled to special lenses (e.g., Morgan therapeutic) and/or to dedicated handpieces (e.g., Lewis), cannulae, catheters, and/or probes. The system is used to remove damaged tissue and/or debris (e.g., foreign objects) for ophthalmic procedures/surgery and in emergency departments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853480006167Viscous Fluid Cannula9849-51TR9849-512016-01-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893872001653iTrack 250ENova Eye, Inc.MRH2026-05-05
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.MRH2025-03-06
00892064002362VIA360 Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-18
00892064002102Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-15
00892064002072Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2023-11-01
00858027006433OMNI Surgical SystemSight Sciences, Inc.MRH2023-10-17
00844685009381TrabEx ProMICROSURGICAL TECHNOLOGY, INC.MRH2022-09-22
00858027006525OMNI Surgical SystemSight Sciences, Inc.MRH2022-08-22
00853704002456iPRIMEGLAUKOS CORPORATIONMRH2022-05-13
00892064002010Streamline® Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2021-11-01
00858027006358OMNI PLUSSight Sciences, Inc.MRH2020-10-30
00858027006372OMNI(R) Surgical System (US)Sight Sciences, Inc.MRH2020-06-01
00858027006334OMNI Surgical System (US)Sight Sciences, Inc.MRH2019-10-25
00893872001585ViscoInjectorNova Eye, Inc.MRH2019-01-28
00858027006310OMNI Surgical System (US)Sight Sciences, Inc.MRH2018-03-16
00858027006013VISCO(TM)360 Viscosurgical SystemSight Sciences, Inc.MRH2016-09-22
00893872001059iTrack 250ANova Eye, Inc.MRH2016-09-15
00853480006242Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006010Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006249Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14