Duns Number:324868165
Device Description: Clip Applying Forceps, detachable10mm, 35 cm for Ethicon clips med./large
Catalog Number
-
Brand Name
Hermann Medizintechnik GmbH
Version/Model Number
H30-135-883E
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
GDO
Product Code Name
Applier, surgical, clip
Public Device Record Key
15cbd8cf-8d02-43bf-abd8-2b4eef449733
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
December 06, 2017
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 |