Duns Number:001292192
Device Description: LANCET QUIKHEEL LAV 0.85MMX1.75MM CE
Catalog Number
368102
Brand Name
BD Microtainer® QuikHeel™ Lancet
Version/Model Number
368102
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
FMK
Product Code Name
Lancet, blood
Public Device Record Key
8d0d3ee4-10cf-42b2-ab89-57c2a0e569de
Public Version Date
November 11, 2020
Public Version Number
1
DI Record Publish Date
November 03, 2020
Package DI Number
30382903681021
Quantity per Package
50
Contains DI Package
50382903681025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |