Duns Number:078684808
Device Description: A collection of sterile devices designed to access and perform a biopsy sample during a lu A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
Catalog Number
10009-09
Brand Name
Archimedies Access Kit with Syringe
Version/Model Number
12196-09
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
K131234
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
093a6a0b-4e29-4a55-bd42-4a8492690034
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2017
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. | 14 |