Duns Number:324868165
Device Description: Dolphine-Nose-Forceps, Ø5mm, WL 330mm, double action jaw, shaft insulated, metal handle/ r Dolphine-Nose-Forceps, Ø5mm, WL 330mm, double action jaw, shaft insulated, metal handle/ ratchet, detachable
Catalog Number
-
Brand Name
Hermann Medizintechnik GmbH
Version/Model Number
H19-533-610
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
f0589285-5550-4d77-9291-7aac7ac7334e
Public Version Date
May 07, 2021
Public Version Number
1
DI Record Publish Date
April 29, 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 |