Lightning Needle

GUDID M896LTN105O1

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Bone marrow biopsy needle, single-use
Primary Device IDM896LTN105O1
NIH Device Record Key6bbb6d79-62cf-42f7-942f-7f355ee6d1de
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightning Needle
Version Model NumberLTN105-O
Company DUNS809012870
Company NameARTERIOCYTE MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM896LTN105O0 [Primary]
HIBCCM896LTN105O1 [Package]
Contains: M896LTN105O0
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-01
Device Publish Date2019-03-23

On-Brand Devices [Lightning Needle]

M896LTN45O1LTN45-O
M896LTN25O1LTN25-O
M896LTN105O1LTN105-O

Trademark Results [Lightning Needle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIGHTNING NEEDLE
LIGHTNING NEEDLE
86478089 not registered Dead/Abandoned
Arteriocyte Medical Systems, Inc.
2014-12-11

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