Duns Number:002348191
Device Description: Pneumothorax Kit
Catalog Number
AK-01500
Brand Name
ARROW
Version/Model Number
IPN033839
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K904021,K904021
Product Code
JDC
Product Code Name
PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Public Device Record Key
56148fa8-5467-44cc-9fa6-3de2d3522ca5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2017
Package DI Number
10801902004809
Quantity per Package
5
Contains DI Package
20801902004806
Package Discontinue Date
June 27, 2017
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |