Duns Number:049290364
Device Description: 5MM DIA., 45CM, JOHAN FENESTRATED GRASPER, 20MM TIP, 3-PIECE MODULAR, SCREW APART, NON-ROT 5MM DIA., 45CM, JOHAN FENESTRATED GRASPER, 20MM TIP, 3-PIECE MODULAR, SCREW APART, NON-ROTATABLE, *SELECT HANDLE TYPE
Catalog Number
52155-41D*
Brand Name
ELMED
Version/Model Number
52155-41D*
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
2fdf4d91-b4a1-40ec-a3b2-fc14430d6e27
Public Version Date
September 21, 2022
Public Version Number
1
DI Record Publish Date
September 13, 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 |