Duns Number:832696038
Device Description: EUFRATE-PASQUE NEEDLE HOLDER SMOOTH TUGSTEN CARBIDE INSERTS OVERALL LENGTH 7" (17.8CM)
Catalog Number
CH2515
Brand Name
V. Mueller
Version/Model Number
CH2515
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
1e165d8b-4d71-4d7c-933a-76e9be7ca0f9
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
August 09, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |