Duns Number:879144426
Device Description: Device is used to maintain intraocular pressure within the posterior chamber during surger Device is used to maintain intraocular pressure within the posterior chamber during surgery
Catalog Number
TR9006-11
Brand Name
Fluid/Gas Tubing Set
Version/Model Number
9006-11
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
K832761,K832761
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
3b2cbe85-9bbd-4bd0-bbf9-953349134671
Public Version Date
September 24, 2018
Public Version Number
4
DI Record Publish Date
January 14, 2016
Package DI Number
10853480006003
Quantity per Package
10
Contains DI Package
00853480006006
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 |