Duns Number:529128653
Device Description: Rescue Single Use Grasping Forceps
Catalog Number
-
Brand Name
Rescue
Version/Model Number
M00527550
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101298,K101298,K101298
Product Code
OCZ
Product Code Name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Public Device Record Key
678f6de4-615d-4909-a1cc-060c1cd819bd
Public Version Date
June 21, 2021
Public Version Number
7
DI Record Publish Date
February 28, 2019
Package DI Number
26948318968620
Quantity per Package
5
Contains DI Package
16948318968807
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |