Duns Number:783518983
Device Description: • 30 Gauge• Twist top lancets• Single use• Provides virtually painless testing• Comfo • 30 Gauge• Twist top lancets• Single use• Provides virtually painless testing• Comfort depth penetration• Smooth tri-bevel point• 100 sterile tip lancets per box
Catalog Number
-
Brand Name
SAPS Healthcare Twist Top lancets 30G
Version/Model Number
7324
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)
Yes
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
61d75eba-1d5d-4273-92c0-c2507ae6347a
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 04, 2018
Package DI Number
10850632007321
Quantity per Package
50
Contains DI Package
00850632007324
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |