Duns Number:783518983
Device Description: • 50 sterile tip lancets per box• 30 Gauge• Twist top lancets• Single use• Provides v
Catalog Number
-
Brand Name
Easy Comfort Twist Top 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
6a919847-970d-4d5b-a8d2-bc57d3966b7b
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 19, 2018
Package DI Number
10850632007314
Quantity per Package
400
Contains DI Package
00850632007317
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 |