Duns Number:597723837
Device Description: SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PP Luer with Isoprene Sleeve, Bulk, SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PP Luer with Isoprene Sleeve, Bulk, Non-Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests
Catalog Number
A100643
Brand Name
SampLok® System with Hinged Lid
Version/Model Number
A100643
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
78aeb187-9a8e-49fd-97d3-243e996c1e65
Public Version Date
April 23, 2019
Public Version Number
2
DI Record Publish Date
March 29, 2019
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |