Duns Number:324868165
Device Description: Scalpel handle number 3, for scalpel blades figure 10-17, length 12cm
Catalog Number
-
Brand Name
Hermann Medizintechnik GmbH
Version/Model Number
H106-10300
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
-
Product Code
GDZ
Product Code Name
HANDLE, SCALPEL
Public Device Record Key
0ab47cfc-5723-4979-ba6f-7b48e0ed8ab7
Public Version Date
November 05, 2021
Public Version Number
1
DI Record Publish Date
October 28, 2021
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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 607 |