Duns Number:711789789
Device Description: DISPOSABLE BIOPSY FORCEPS
Catalog Number
-
Brand Name
DISPOSABLE BIOPSY FORCEPS
Version/Model Number
FB-211D
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
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
7bb34a22-e538-434a-a556-8470327efdc3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
14953170158121
Quantity per Package
20
Contains DI Package
04953170158124
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |