Duns Number:961027315
Device Description: Stethoscope, Premium Stainless, Dual Head, Adult, Burgurndy
Catalog Number
SPD57ABG
Brand Name
CARDINAL HEALTH
Version/Model Number
SPD57ABG
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)
-
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
63691f0c-bb51-4cf8-873a-e61d26d47681
Public Version Date
June 05, 2019
Public Version Number
1
DI Record Publish Date
May 28, 2019
Package DI Number
10888499005136
Quantity per Package
10
Contains DI Package
00888499005139
Package Discontinue Date
-
Package Status
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 |