Duns Number:007941230
Device Description: Curette Ear Scoop 2 Mil Tip Single-Use Disposable Polypropylene Not Made With Natural Rubb Curette Ear Scoop 2 Mil Tip Single-Use Disposable Polypropylene Not Made With Natural Rubber Latex Gray For Infant MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
CUR1031
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JYG
Product Code Name
CURETTE, EAR
Public Device Record Key
5d1f8717-ffd3-46ae-8fea-92e97154d6f8
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2020
Package DI Number
50885632133723
Quantity per Package
10
Contains DI Package
30885632133729
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |