Duns Number:783518983
Device Description: • 100 sterile tip lancets per box• 30 Gauge• Twist top lancets• Single use• Provides • 100 sterile tip lancets per box• 30 Gauge• Twist top lancets• Single use• Provides virtually painless testing• Comfort depth penetration• Smooth tri-bevel point
Catalog Number
-
Brand Name
SHAN Medical Easy Comfort Lancets 30G
Version/Model Number
1164
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
b560bfd5-15a4-4489-a498-7921a5bd43c6
Public Version Date
March 23, 2020
Public Version Number
1
DI Record Publish Date
March 13, 2020
Package DI Number
10850632007529
Quantity per Package
200
Contains DI Package
00850632007522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |