Duns Number:079641356
Device Description: Rosen Suction Tube 15 Gauge, 2"
Catalog Number
61-1035
Brand Name
Symmetry Surgical
Version/Model Number
61-1035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 9999
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
-
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
-
Product Code
JZF
Product Code Name
Tube, Ear Suction
Public Device Record Key
0f545add-90ca-4d8d-9e0a-2c0f7f80e9a1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 14, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7981 |
2 | A medical device with a moderate to high risk that requires special controls. | 3309 |