Duns Number:801895244
Device Description: Injection Pipette
Catalog Number
-
Brand Name
TPC
Version/Model Number
LICR-SBS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUC
Product Code Name
Microtools, Assisted Reproduction (Pipettes), Exempt
Public Device Record Key
b94aa33f-21e3-49a8-bd10-7ba9cdc34cef
Public Version Date
April 13, 2020
Public Version Number
1
DI Record Publish Date
April 03, 2020
Package DI Number
20888937023538
Quantity per Package
10
Contains DI Package
00888937023534
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |