Duns Number:781772017
Device Description: Elastics Neon Medium 3/8" Sea Turtle 50 pks of 100
Catalog Number
-
Brand Name
Creatures of the Sea
Version/Model Number
500-405
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2022
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECI
Product Code Name
BAND, ELASTIC, ORTHODONTIC
Public Device Record Key
63d2c881-5e80-4993-8e24-c4d9ad73f8db
Public Version Date
April 27, 2022
Public Version Number
3
DI Record Publish Date
July 26, 2017
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 | 7987 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 663 |