Duns Number:324868165
Device Description: Biopsy forceps with thorn, Ø5mm, WL 330mm, double action jaw, shaft insulated, metal handl Biopsy forceps with thorn, Ø5mm, WL 330mm, double action jaw, shaft insulated, metal handle/ ratchet, detachable
Catalog Number
-
Brand Name
Hermann Medizintechnik GmbH
Version/Model Number
H35-533-661
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
K051610
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
e34389ad-9ca7-440b-9d6a-15194ce1da01
Public Version Date
May 13, 2021
Public Version Number
1
DI Record Publish Date
May 05, 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 |