Duns Number:064608573
Device Description: HCG Total (ThCG) - Atellica IM - RGT - 450T
Catalog Number
11206261
Brand Name
Atellica IM ThCG
Version/Model Number
11206261
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172322,K172322
Product Code
JHI
Product Code Name
Visual, pregnancy hCG, prescription use
Public Device Record Key
9b6c7f7c-5222-45e8-8972-0e8150a0f7fc
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
May 31, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |