Duns Number:316305242
Catalog Number
-
Brand Name
Pump tube, single use
Version/Model Number
4170.229
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K033927,K033927
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
ffbaba2a-8f05-4451-8180-0a9fe86ef731
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
December 14, 2016
Package DI Number
04056702002510
Quantity per Package
10
Contains DI Package
04056702002503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |