Duns Number:054318779
Device Description: Stethoscope Black, high luster chrome plated binaural with long life rugged 22 inch double Stethoscope Black, high luster chrome plated binaural with long life rugged 22 inch double tube. 3 sets of ear tips.
Catalog Number
416-22-BLK
Brand Name
Omron Sprague Rappaport Stethoscope
Version/Model Number
416-22-BLK
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
28f07b95-bed5-4771-87fe-ff31b9f53560
Public Version Date
July 21, 2020
Public Version Number
1
DI Record Publish Date
July 13, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |