Viscous Fluid Pack TR8170-51

GUDID 10853480006249

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.

ESCALON MEDICAL CORP.

Eye-surface lavage system
Primary Device ID10853480006249
NIH Device Record Keyca2961b8-4f9d-4125-970f-5134746734a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameViscous Fluid Pack
Version Model Number8170-51
Catalog NumberTR8170-51
Company DUNS879144426
Company NameESCALON MEDICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-486-4848
Emailinfo@escalonmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853480006242 [Primary]
GS110853480006249 [Package]
Contains: 00853480006242
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRHPump, Infusion, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-14

On-Brand Devices [Viscous Fluid Pack]

10853480006249Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids.
10853480006010Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids.

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