Duns Number:342582423
Device Description: DENTAL CARTRIDGE SYRINGE ASTRA WITH ASPIRATION, 1.8 ML, UNC TREAD
Catalog Number
SD-8NA
Brand Name
BMT Medizintechnik GmbH
Version/Model Number
SD-8NA
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"
Yes
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
EIC
Product Code Name
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
Public Device Record Key
80e0c181-4262-432a-b102-fec65287c487
Public Version Date
May 13, 2020
Public Version Number
1
DI Record Publish Date
May 05, 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 | 2079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |