Duns Number:049290364
Device Description: 5MM, 45CM NEEDLE HOLDER, CURVED LEFT TUNGSTEN CARBIDE TIP, ERGONOMIC CURVED DOWN SINGLE AC 5MM, 45CM NEEDLE HOLDER, CURVED LEFT TUNGSTEN CARBIDE TIP, ERGONOMIC CURVED DOWN SINGLE ACTION AXIAL HANDLE W/ RATCHET, FLUSHPORT
Catalog Number
52515-71
Brand Name
ELMED
Version/Model Number
52515-71
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
K181173
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
74e4076e-4053-49ff-998e-759c6da13315
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 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 |