Duns Number:311231554
Device Description: LP Focus Workst. system, UK
Catalog Number
-
Brand Name
Alpine BioMed
Version/Model Number
9033A0821BV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 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
-
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
K140680
Product Code
GZL
Product Code Name
Electrode, Depth
Public Device Record Key
5e3f4eac-6f00-4c6e-98bc-8f7a8f7acea4
Public Version Date
April 29, 2020
Public Version Number
4
DI Record Publish Date
August 25, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 191 |