Duns Number:044668515
Device Description: NECK STRAP ORTHO BAND WITH SAFETY CHAIN 3/4" BLUE ADJUSTABLE 10/PK
Catalog Number
852-756
Brand Name
Ortho Band
Version/Model Number
852-756
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 14, 2020
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
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
017e4d9d-3380-49eb-bd9c-b6b1b9fc96c1
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
December 07, 2016
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 |