Duns Number:049290364
Device Description: "5MM,36CM,CLEAR FLUSH DEBAKEY GRASPER, RADEL INSULATION ROTATBLE, ONE PIECE, NON-INSULATED "5MM,36CM,CLEAR FLUSH DEBAKEY GRASPER, RADEL INSULATION ROTATBLE, ONE PIECE, NON-INSULATED STAINLESS STEEL W/ RATCHET "
Catalog Number
5-0536-222B
Brand Name
ELMED
Version/Model Number
5-0536-222B
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
e10bdb05-3b69-4dac-b0cd-72039c058d43
Public Version Date
February 03, 2022
Public Version Number
1
DI Record Publish Date
January 26, 2022
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4068 |