Duns Number:077801124
Device Description: ULTIMATE Ball Clasps .036
Catalog Number
-
Brand Name
OSE
Version/Model Number
A186-130
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECO
Product Code Name
Spring, Orthodontic
Public Device Record Key
f33dc863-5165-4181-842d-da2f20329809
Public Version Date
May 12, 2020
Public Version Number
1
DI Record Publish Date
May 04, 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 | 389 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |