Duns Number:106793995
Device Description: Container, Fecal, 30mL, Attached Screw Cap with Spoon, PP, Conical Bottom, Self-Standing, Container, Fecal, 30mL, Attached Screw Cap with Spoon, PP, Conical Bottom, Self-Standing, Attached ID Label, 50/Bag, 10 Bags/Unit
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
109120L
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
NNI
Product Code Name
Container, Specimen, Non-Sterile
Public Device Record Key
1cbc1030-0ccd-443b-bc23-823b1a6718e6
Public Version Date
December 05, 2019
Public Version Number
1
DI Record Publish Date
November 27, 2019
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 |