Duns Number:007941230
Device Description: Stethoscope Lightweight Single-head Assembled Blue Not Made With Natural Rubber Latex Pvc Stethoscope Lightweight Single-head Assembled Blue Not Made With Natural Rubber Latex Pvc Tubing With Dinp MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
STH4610
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"
Yes
For Single-Use
Yes
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
7c5ba81b-adcf-43af-98fa-84c01fd86a3e
Public Version Date
December 17, 2020
Public Version Number
2
DI Record Publish Date
October 14, 2020
Package DI Number
20885632139649
Quantity per Package
30
Contains DI Package
10885632139642
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |