Viscous Fluid Pack - Single-use procedure pack for injection and - ESCALON MEDICAL CORP.

Duns Number:879144426

Device Description: Single-use procedure pack for injection and aspiration of silicone oil and other viscous f Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Alcon systems. 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

TR8170-51

Brand Name

Viscous Fluid Pack

Version/Model Number

8170-51

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K963434,K963434

Product Code Details

Product Code

MRH

Product Code Name

Pump, Infusion, Ophthalmic

Device Record Status

Public Device Record Key

ca2961b8-4f9d-4125-970f-5134746734a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 14, 2016

Additional Identifiers

Package DI Number

10853480006249

Quantity per Package

10

Contains DI Package

00853480006242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ESCALON MEDICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 12