Duns Number:106793995
Device Description: STAT red specimen bag, zip lock 6x9" with document pouch
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
4950A
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
70952703-ace5-4102-ae9f-c911e7cc7f74
Public Version Date
January 28, 2022
Public Version Number
2
DI Record Publish Date
December 29, 2021
Package DI Number
00840095630498
Quantity per Package
10
Contains DI Package
00840095648455
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 | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |