Duns Number:021717889
Device Description: Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Catalog Number
-
Brand Name
Acquire
Version/Model Number
M00555580
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
FCG
Product Code Name
Biopsy needle
Public Device Record Key
5014b24f-6c4c-46bf-a144-75655329321d
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
March 01, 2017
Package DI Number
08714729931881
Quantity per Package
5
Contains DI Package
08714729931829
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |