Duns Number:003530786
Device Description: The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective style The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.
Catalog Number
90201
Brand Name
Pediatric Stylet
Version/Model Number
90201
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
BSR
Product Code Name
Stylet, Tracheal Tube
Public Device Record Key
59c03680-6d14-4158-ac5e-472d83baed4b
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
10859290006356
Quantity per Package
20
Contains DI Package
00859290006359
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |