Duns Number:658869745
Device Description: IMEDIPLUS TS-3000S Wine Red Single Head Stethoscope aids to the auscultation needs and is IMEDIPLUS TS-3000S Wine Red Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
Catalog Number
-
Brand Name
IMEDIPLUS TS-3000S Single Head Stethoscope Wine Red
Version/Model Number
TS-3000S Wine Red
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
-
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
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
4661a77b-17f9-4fd6-89db-a02166539a5f
Public Version Date
July 01, 2020
Public Version Number
1
DI Record Publish Date
June 23, 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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |