Hopkins Medical Products® - OneStep+ Lancet 1.8mm Grey 100/PK - HOPKINS UNIFORM COMPANY

Duns Number:003080678

Device Description: OneStep+ Lancet 1.8mm Grey 100/PK

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More Product Details

Catalog Number

592011

Brand Name

Hopkins Medical Products®

Version/Model Number

592011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K101145

Product Code Details

Product Code

FMK

Product Code Name

Lancet, blood

Device Record Status

Public Device Record Key

a4c8b4b5-cadd-4b87-95e6-fc720ab1c9bf

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOPKINS UNIFORM COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 96
2 A medical device with a moderate to high risk that requires special controls. 135