Duns Number:080545263
Device Description: Tag Applicator 10 cm, Single
Catalog Number
-
Brand Name
LOCalizer
Version/Model Number
HB200-10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
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
NEU
Product Code Name
Marker, Radiographic, Implantable
Public Device Record Key
16d404de-d86c-4f90-8db8-6651df45033f
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
May 03, 2018
Package DI Number
10855436007041
Quantity per Package
10
Contains DI Package
00855436007044
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. | 9 |