Duns Number:021192653
Device Description: AS-916 Liquid Dental Transport Medium (LDT) is a buffered mineral salt based liquid medium AS-916 Liquid Dental Transport Medium (LDT) is a buffered mineral salt based liquid medium with reducing agents designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 1 mL fill volume. 19 x 40 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack.
Catalog Number
AS-916
Brand Name
PRAS Liquid Dental Transport Medium (LDT)
Version/Model Number
AS-916
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSL
Product Code Name
Culture Media, Anaerobic Transport
Public Device Record Key
e1b6375d-64dc-41f4-8af6-07169bb11888
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 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 | 148 |