Duns Number:787828537
Device Description: Chest piece with two functions. The binaural head frame is made seamless brass tubes. Thic Chest piece with two functions. The binaural head frame is made seamless brass tubes. Thick walled 22" PVC tubing, durable and noise proof. Comfortable smooth plastic ear plugs. Mixed Colors.
Catalog Number
-
Brand Name
ViaMed
Version/Model Number
13410-MIX
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
14a2ead5-5906-4c67-b5ee-b81e66d69d1b
Public Version Date
December 07, 2020
Public Version Number
1
DI Record Publish Date
November 27, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |