Duns Number:109903521
Device Description: DUCKLING PUNCH BASKET ELEVATOR LOOP HANDLE
Catalog Number
014765
Brand Name
DUCKLING
Version/Model Number
014765
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
NBH
Product Code Name
ACCESSORIES,ARTHROSCOPIC
Public Device Record Key
380fa257-440b-42e9-ad75-cb918d817067
Public Version Date
October 09, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2015
Package DI Number
00885554007640
Quantity per Package
1
Contains DI Package
03596010026286
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
EA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |