Duns Number:600850213
Device Description: Slide Mailer, Holds 5 slides of 25.0X75.0MM (1"X3"), polypropylene, clear
Catalog Number
-
Brand Name
Microscope Slide Mailer
Version/Model Number
SM0101
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
NNK
Product Code Name
Container, Specimen Mailer And Storage, Non-Sterile
Public Device Record Key
4746edff-4bab-4670-90da-3d1bbc0bf2bd
Public Version Date
February 25, 2022
Public Version Number
1
DI Record Publish Date
February 17, 2022
Package DI Number
10810050854365
Quantity per Package
100
Contains DI Package
00810050854368
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |