Duns Number:071595540
Device Description: Precisor Broncho Pulmonary Costed Disposable Biopsy Forceps
Catalog Number
100503
Brand Name
Precisor Broncho
Version/Model Number
100503
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"
-
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
b340873a-bd48-47c5-831c-d17c08bbce57
Public Version Date
December 07, 2020
Public Version Number
1
DI Record Publish Date
November 28, 2020
Package DI Number
10653405052111
Quantity per Package
10
Contains DI Package
30653405052115
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |