Duns Number:106793995
Device Description: 16x101mm tube, separate red screwcap, sterile, self-standing,200 tube/bag,1000cap/bag,case 16x101mm tube, separate red screwcap, sterile, self-standing,200 tube/bag,1000cap/bag,case liner.
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
6102S-R
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
19388ce7-47b8-4218-bf0e-97953521bab6
Public Version Date
October 16, 2020
Public Version Number
1
DI Record Publish Date
October 08, 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 | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |