Duns Number:012430880
Device Description: Otoscope Disp Tips Ear Spec
Catalog Number
1125528
Brand Name
Henry Schein
Version/Model Number
1125528
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
Yes
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
ERA
Product Code Name
OTOSCOPE
Public Device Record Key
dc75e10c-c3ec-433c-9e5b-bea2e60c0ab0
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
December 21, 2018
Package DI Number
20304040029200
Quantity per Package
24
Contains DI Package
10304040029203
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |