Duns Number:109903521
Device Description: ACHIEVECAS REFLECTION PASSIVE SPHERES 4 QUANTITY 1 PACK ACHIEVECAS REFLECTION PASSIVE SPHERES 4 QUANTITY 1 PACK STERILE
Catalog Number
74482004
Brand Name
ACHIEVECAS
Version/Model Number
74482004
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
K041369,K041369
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
fe31a4a1-7ee1-46d1-8f95-ae7dcbd35c91
Public Version Date
October 22, 2020
Public Version Number
4
DI Record Publish Date
September 28, 2015
Package DI Number
23596010544111
Quantity per Package
4
Contains DI Package
03596010544117
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |