Duns Number:108179458
Device Description: microTargeting STar Array Insertion Tube Extractor, 5x, Sterile, for use the STar Array In microTargeting STar Array Insertion Tube Extractor, 5x, Sterile, for use the STar Array Insertion Tubes
Catalog Number
70-CN-ET
Brand Name
microTargeting™ STar™ Array Insertion Tube Extractor
Version/Model Number
70-CN-ET-00236
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
HAO
Product Code Name
INSTRUMENT, SURGICAL, NON-POWERED
Public Device Record Key
292bd06e-d159-4249-972b-9b94849f3ce4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
10873263002367
Quantity per Package
5
Contains DI Package
00873263002360
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK/5
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 476 |