Duns Number:600850213
Device Description: Sterile Transport Tube - 5 ML - Caps Separate
Catalog Number
TC0101
Brand Name
Transport Tubes - Sterile
Version/Model Number
TC0101
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
KDT
Product Code Name
Container, Specimen Mailer And Storage, Sterile
Public Device Record Key
ff848c4c-f806-4ea3-81e3-58f6c431b154
Public Version Date
September 10, 2020
Public Version Number
1
DI Record Publish Date
September 02, 2020
Package DI Number
00810050852418
Quantity per Package
1000
Contains DI Package
00810050852401
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 39 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |