Duns Number:784143778
Device Description: The ALPCO Easy Stool Extraction Device is intended for the storage and preparation of huma The ALPCO Easy Stool Extraction Device is intended for the storage and preparation of human stool samples for examination. For In Vitro Diagnostic Use.
Catalog Number
30-EZEX-100
Brand Name
Easy Stool Extraction Device
Version/Model Number
30-EZEX-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
NNK
Product Code Name
Container, Specimen Mailer And Storage, Non-Sterile
Public Device Record Key
1113caae-13ee-4e77-b4fe-0132faf5f889
Public Version Date
November 06, 2020
Public Version Number
2
DI Record Publish Date
July 17, 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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |