Duns Number:315304071
Device Description: OPT. GRASPING FORCEPS PIKE-MOUTH double-action, for grasping foreign bodies, for sheaths OPT. GRASPING FORCEPS PIKE-MOUTH double-action, for grasping foreign bodies, for sheaths from 14Fr, for telescope 0° Ø, for telescope 0° Ø 2.7mm, with twist lock, reusable
Catalog Number
8672.654
Brand Name
E-LINE
Version/Model Number
8672654
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
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
44d627cc-b798-41a2-ad0e-1ed00804331b
Public Version Date
July 20, 2021
Public Version Number
5
DI Record Publish Date
September 28, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |