Duns Number:597723837
Device Description: SampLok® Hinged Lid 11-18 (Wider Bore), Clear, Bulk, Non-Sterile; Intended as a needle hol SampLok® Hinged Lid 11-18 (Wider Bore), Clear, Bulk, Non-Sterile; Intended as a needle holder for a Luer adapter needle to vacuum blood collection tube.
Catalog Number
A100422
Brand Name
SampLok® With Hinged Lid
Version/Model Number
A100422
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
K000777,K000777
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
2d950c2c-ad3d-42de-ae96-cfbc3f83a5e1
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 |