Duns Number:825239189
Device Description: Endoscopic Biopsy Forceps with Needle, Coated, Cold
Catalog Number
ET1413
Brand Name
BioCeps Biopsy Forceps
Version/Model Number
ET1413
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
d42c491b-e18c-436a-8d63-902e5caa02ce
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 29, 2021
Package DI Number
10816207021475
Quantity per Package
10
Contains DI Package
00816207021478
Package Discontinue Date
-
Package Status
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |