Duns Number:314648911
Device Description: Bip. coag. forceps, Ø5mm, l=450mm Tong-type, bit 3 mm, d/a Spring han Bip. coag. forceps, Ø5mm, l=450mm Tong-type, bit 3 mm, d/a Spring handle, w. flat plug
Catalog Number
LBF-504-450
Brand Name
DANmed
Version/Model Number
LBF-504-450
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2022
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"
Yes
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
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
546d11af-8194-4263-a53d-d7496a3f26fa
Public Version Date
August 31, 2022
Public Version Number
3
DI Record Publish Date
March 15, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2000 |