Duns Number:628380248
Device Description: SurgiLance Safety Lancet, 21G Needle, 2.2 mm, Orange
Catalog Number
-
Brand Name
SurgiLance Safety Lancet
Version/Model Number
SLN240
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101145,K101145,K101145
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
3e93b29e-863d-4ebb-b3c2-bacc3b6b370d
Public Version Date
November 15, 2021
Public Version Number
5
DI Record Publish Date
January 02, 2017
Package DI Number
58886354701056
Quantity per Package
15
Contains DI Package
38886354701052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |