FDA.reportPublic FDA data

Irrigating Contact Lens

Primary DI
00853480006136
Brand
Irrigating Contact Lens
Company
ESCALON MEDICAL CORP.
Model
Flat
Catalog number
TR9840-11
Device description
For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single -use requiring no clean up.
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
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924999000AUTOPOLE REGULATOR SYSTEMEscalon Trek Medical1992-12-24KYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853480006136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853480006136008534800061368534800061360853480006136

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy contact lens, single-useA sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
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B090MT2020MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
G22312647930Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2025-11-05
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20000MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
08052276027290Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2025-06-04
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
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G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
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08052276026354Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08052276026361Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
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