Duns Number:806806220
Device Description: Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm Seamless Viral Barrier Adhesive Box End, Polyurethane, 1" x 3.2" Face to 6"W x 48"L (2.5cm x 8.1cm Face to 15.2cm x 122cm), 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) & Adapter, Tilt-Out Style
Catalog Number
-
Brand Name
Sheathes3D
Version/Model Number
ADH-65-IL486-22110-3
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
78730f1b-7fdc-45aa-8c81-26a2d56dcbe8
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
20842418104376
Quantity per Package
3
Contains DI Package
10842418104379
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 |