Duns Number:129278169
Catalog Number
211201602
Brand Name
END CAP REMOVAL TOOL
Version/Model Number
2112-01-602
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
HWB
Product Code Name
EXTRACTOR
Public Device Record Key
9681ce52-b63f-40e4-82a8-2f9a6e1a1572
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
April 18, 2017
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 | 11962 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28376 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |