Duns Number:600166524
Catalog Number
-
Brand Name
Aspiration Disposables Kit
Version/Model Number
Aspiration Disposables Kit
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
be08a81f-fad5-461a-bcd8-9f86f61c3ad5
Public Version Date
October 18, 2021
Public Version Number
5
DI Record Publish Date
September 07, 2016
Package DI Number
17290109142040
Quantity per Package
6
Contains DI Package
07290109142043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 361 |