Duns Number:806806220
Device Description: Polyurethane, 5"W x 48"L, Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 El Polyurethane, 5"W x 48"L, Sterile, Ultrasound Needle Guide Kit with 20ml Sterile Gel, 2 Elastics, Three 21g Needle Guide Sets (1 Each of 1.0, 1.5, & 2.0cm), Tilt-Out Style
Catalog Number
-
Brand Name
Sheathes
Version/Model Number
65-485-12110-3
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
cfefa3de-67bf-4d7b-b738-2265d8301c4c
Public Version Date
September 10, 2018
Public Version Number
1
DI Record Publish Date
August 08, 2018
Package DI Number
20842418103911
Quantity per Package
3
Contains DI Package
10842418103914
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |