Duns Number:628380248
Device Description: SurgiLance Lite Safety Lancet, 28G, 2.2mm Orange, Bag of 10/bag
Catalog Number
-
Brand Name
SurgiLance Lite Safety Lancet
Version/Model Number
SLL28G221
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
-
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
2e160a25-6940-4603-856b-07ef88416681
Public Version Date
November 15, 2021
Public Version Number
4
DI Record Publish Date
January 02, 2017
Package DI Number
58886354702589
Quantity per Package
350
Contains DI Package
28886354702588
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 |