Duns Number:627879687
Device Description: The Centra biopsy forceps is used to enter human gastrointestinal tract via flexible endos The Centra biopsy forceps is used to enter human gastrointestinal tract via flexible endoscope to obtain tissue sample in order to understand disease pathology.
Catalog Number
00711247
Brand Name
Centra
Version/Model Number
00711247
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
4bec1d31-f9fd-4085-a021-d50e4af63767
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
10724995180628
Quantity per Package
10
Contains DI Package
00724995180621
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 |