Duns Number:058614483
Device Description: Extendable Extension Tube
Catalog Number
-
Brand Name
DAR
Version/Model Number
332U5663
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
BZA
Product Code Name
CONNECTOR, AIRWAY (EXTENSION)
Public Device Record Key
6656135e-3c6c-4fdd-a1be-f03abb59bc3a
Public Version Date
April 08, 2021
Public Version Number
7
DI Record Publish Date
August 19, 2018
Package DI Number
20884522032756
Quantity per Package
25
Contains DI Package
10884522032759
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 132 |
2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
3 | A medical device with high risk that requires premarket approval | 202 |
U | Unclassified | 40 |