Duns Number:324869601
Device Description: Stylet for tube I.D. 7,0 - 11,0 mm
Catalog Number
-
Brand Name
n.a.
Version/Model Number
90-10-004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
BSR
Product Code Name
Stylet, Tracheal Tube
Public Device Record Key
749ebd62-0f3f-45de-bc1a-683a6a547fb0
Public Version Date
September 12, 2022
Public Version Number
3
DI Record Publish Date
August 04, 2020
Package DI Number
14250105608967
Quantity per Package
10
Contains DI Package
04250105608960
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 | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |