Duns Number:830016148
Device Description: 3M™ Littmann® CORE Digital Stethoscope, 8838, High Polish Copper Chestpiece, Black Tube, S 3M™ Littmann® CORE Digital Stethoscope, 8838, High Polish Copper Chestpiece, Black Tube, Stem and Headset, 27 inch
Catalog Number
8838
Brand Name
3M™ Littmann®
Version/Model Number
8838
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQD
Product Code Name
STETHOSCOPE, ELECTRONIC
Public Device Record Key
257eb8bb-ef78-4dfd-8771-df9c1019c907
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 05, 2021
Package DI Number
50707387793956
Quantity per Package
3
Contains DI Package
00707387793951
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |