Duns Number:134614411
Device Description: Sterile tracking bracket for use with Hologic Celero biopsy instrument
Catalog Number
653-001
Brand Name
Tracking Bracket
Version/Model Number
653-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 19, 2020
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
K092619,K092619
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
d478d539-2685-4f46-98ba-073a381411ff
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
August 22, 2017
Package DI Number
00841436106047
Quantity per Package
12
Contains DI Package
10841436106044
Package Discontinue Date
May 19, 2020
Package Status
Not 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |