Catalog Number

-

Brand Name

SurgiLance Safety Lancet

Version/Model Number

SLN300S

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

38274963-ad47-4b49-892e-390f8dd9f47d

Public Version Date

November 15, 2021

Public Version Number

5

DI Record Publish Date

January 02, 2017

Package DI Number

58886354702220

Quantity per Package

15

Contains DI Package

38886354702226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case