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 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.
Catalog Number
TR8170-11
Brand Name
Viscous Fluid Pack
Version/Model Number
8170-11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
MRH
Product Code Name
Pump, Infusion, Ophthalmic
Public Device Record Key
1bcc07e2-4975-49fc-944a-a20c46e0aa48
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 14, 2016
Package DI Number
10853480006010
Quantity per Package
10
Contains DI Package
00853480006013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |