Duns Number:092312735
Device Description: DIABETIC SPECIMEN CONTAINER 6/72DIABETIC SPECIMEN CONTAINER 6CT 1/12
Catalog Number
-
Brand Name
Diabetic Specialty Solutions
Version/Model Number
66949/66949AZ
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
e2c6f850-833f-40b0-b49d-7e278bf526cd
Public Version Date
September 18, 2020
Public Version Number
1
DI Record Publish Date
September 10, 2020
Package DI Number
20025715669490
Quantity per Package
6
Contains DI Package
00025715669502
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |