Duns Number:627879687
Device Description: The disposable Raptor grasping device-mini is be used to grasp tissue and/or retrieve fore The disposable Raptor grasping device-mini is be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
Catalog Number
00711178
Brand Name
Raptor
Version/Model Number
00711178
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 2020
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"
Yes
For Single-Use
Yes
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
OCZ
Product Code Name
Endoscopic grasping/cutting instrument, non-powered
Public Device Record Key
c08db5f8-17ab-4ce3-b820-6586e32cbbb7
Public Version Date
March 17, 2020
Public Version Number
6
DI Record Publish Date
September 19, 2016
Package DI Number
10816765012564
Quantity per Package
5
Contains DI Package
00816765012567
Package Discontinue Date
March 17, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |