Duns Number:006421325
Device Description: HumatroPen 12 mg is a reusable pen injector intended for use with Humatrope 12 mg cartridg HumatroPen 12 mg is a reusable pen injector intended for use with Humatrope 12 mg cartridges
Catalog Number
MS9561
Brand Name
HumatroPen® 12 mg
Version/Model Number
MS9561
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
fd1a56be-1783-49fc-96a3-fe8be718cc05
Public Version Date
September 24, 2019
Public Version Number
1
DI Record Publish Date
September 16, 2019
Package DI Number
30300029561010
Quantity per Package
20
Contains DI Package
00300029561019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |