Duns Number:025460908
Device Description: STETHOSCOPE, DUAL-HEAD, RED
Catalog Number
MDS926206CS
Brand Name
Medline
Version/Model Number
MDS926206CS
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
-
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
9af43544-c52b-4b1d-971c-6e26b2fb8dba
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
30080196716313
Quantity per Package
25
Contains DI Package
00080196716312
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |