Duns Number:368444471
Device Description: DC-Air™ Holder Pack is intended to position and to hold x-ray sensor inside the mouth of t DC-Air™ Holder Pack is intended to position and to hold x-ray sensor inside the mouth of the patient.
Catalog Number
-
Brand Name
DC-Air™ Holder Pack
Version/Model Number
DC-HP-1
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
-
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
EGZ
Product Code Name
Holder, Film, X-Ray
Public Device Record Key
6b842c88-6030-4ff6-b820-0106ed07e2a9
Public Version Date
May 03, 2022
Public Version Number
2
DI Record Publish Date
March 10, 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 | 1 |