US DIAGNOSTICS

GUDID 00857513006667

Shandong Lianfa Medical Plastic Products CO.,LTD

Blood lancet, single-use
Primary Device ID00857513006667
NIH Device Record Keyf9268aaf-77ca-4780-b2d0-5a647230cc76
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS DIAGNOSTICS
Version Model NumberLD-F-II
Company DUNS421330121
Company NameShandong Lianfa Medical Plastic Products CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857513006667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
QRLMultiple Use Blood Lancet For Single Patient Use Only

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

On-Brand Devices [US DIAGNOSTICS]

00885502007029Sterile Lancets 30G
56949517070399Single-Use Safety Lancets, 28G, 100/box
00857513006667LD-F-II

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