Duns Number:316074384
Device Description: Ortho Easy Pin pink anodized .022" 1,7 x 8 mm (5 pcs.)
Catalog Number
-
Brand Name
OrthoEasy®
Version/Model Number
1101A2308
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110275,K110275
Product Code
OAT
Product Code Name
Implant, endosseous, orthodontic
Public Device Record Key
20bf0b02-140d-485f-8f85-f235082b8228
Public Version Date
August 23, 2019
Public Version Number
1
DI Record Publish Date
August 15, 2019
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 | 5082 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 941 |