Duns Number:145963778
Device Description: Spectrum Disposable AirWater Syringe Tips in Assorted Colors that Deliver Dry Air on Dema Spectrum Disposable AirWater Syringe Tips in Assorted Colors that Deliver Dry Air on Demand
Catalog Number
-
Brand Name
Seal-Tight
Version/Model Number
72200C
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
K951238,K951238
Product Code
EIA
Product Code Name
UNIT, OPERATIVE DENTAL
Public Device Record Key
6806d46e-bb13-4d13-a795-14e7c78b5c31
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |