Duns Number:044668515
Device Description: TUBE MINI MAND RIGHT 1ST MOLAR 018/045 CAST CONV TQ=-25 R=5 3.5MM W/HOOK HG GING
Catalog Number
004-568LB
Brand Name
Buccal Tubes
Version/Model Number
004-568LB
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZD
Product Code Name
TUBE, ORTHODONTIC
Public Device Record Key
fa4ef444-9bf5-4b4e-883f-b5fc1be025b7
Public Version Date
April 01, 2022
Public Version Number
1
DI Record Publish Date
March 24, 2022
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 | 16634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |