Duns Number:627879687
Device Description: The Moray micro forceps is designed to enhance sampling from lesions that can occur within The Moray micro forceps is designed to enhance sampling from lesions that can occur within and outside of the gastrointestinal tract.
Catalog Number
00711889
Brand Name
Moray
Version/Model Number
00711889
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCL
Product Code Name
FORCEPS, BIOPSY, NON-ELECTRIC
Public Device Record Key
7adb8db4-6818-4ffd-9bee-0c0ba7c0ec28
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
10724995184091
Quantity per Package
3
Contains DI Package
00724995184094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |