Safety Lancet (30G) - Pressure Activated Safety Lancet (Bag of 100 - Shandong Lianfa Medical Plastic Products CO.,LTD

Duns Number:421330121

Device Description: Pressure Activated Safety Lancet (Bag of 100 lancets), radiation (gamma) sterilization

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More Product Details

Catalog Number

-

Brand Name

Safety Lancet (30G)

Version/Model Number

LF-PA-30

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

-

Product Code Details

Product Code

FMK

Product Code Name

Lancet, Blood

Device Record Status

Public Device Record Key

b7f58f64-4ee6-42b6-a371-54387de93de8

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37