Duns Number:527812392
Device Description: Surgical irrigation/aspiration handpiece, single-use
Catalog Number
-
Brand Name
MEDLINE
Version/Model Number
89056NS
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
-
Product Code
FHF
Product Code Name
System, Evacuator, Fluid
Public Device Record Key
3b979f91-e7d7-4f52-97b1-64272d55a8f0
Public Version Date
August 21, 2019
Public Version Number
4
DI Record Publish Date
December 16, 2017
Package DI Number
26939029815174
Quantity per Package
4
Contains DI Package
16939029815177
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 165 |