Safety Lancet PAII (23G) - Safety Lancet PAII (Box of 50 Lancets), - Shandong Lianfa Medical Plastic Products CO.,LTD

Duns Number:421330121

Device Description: Safety Lancet PAII (Box of 50 Lancets), Sterilized with Irradiation

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More Product Details

Catalog Number

-

Brand Name

Safety Lancet PAII (23G)

Version/Model Number

LF-PAII-23

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

5d542594-ded3-49d0-8546-3de793b19efd

Public Version Date

July 21, 2021

Public Version Number

2

DI Record Publish Date

May 20, 2020

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