Duns Number:961027315
Device Description: STETHOSCOPE SINGLE HEAD ALUMINUM CHEST PIECE INFANT SINGLE PATIENT USE LIGHT PINK
Catalog Number
SMS11NPK
Brand Name
CARDINAL HEALTH
Version/Model Number
SMS11NPK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
095a6807-67ba-48df-9597-5138d6c5ab07
Public Version Date
December 31, 2021
Public Version Number
3
DI Record Publish Date
June 06, 2019
Package DI Number
10888499001923
Quantity per Package
10
Contains DI Package
00888499001926
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |