Lightning Needle

Primary DI
M896LTN45O1
Brand
Lightning Needle
Company
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Model
LTN45-O
Published
2019-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141910000Intraosseous Cannula System Bio-MAC¿ and Bio-COREBiologic Therapies, Inc.2015-05-04KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M896LTN45O1PackageHIBCC1In Commercial Distribution
M896LTN45O0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809012870
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M896AMS1000Magellan Autologous Platelet Separator SystemAMS100AMS1002016-09-09
M896AMS3000Magellan Complete Disposable KitAMS300AMS3002016-09-12
M896AMS3050Magellan Basic disposable kitAMS305AMS3052016-09-12
M896AMS3100Magellan Complete One Source KitAMS310AMS3102016-09-12
M896BTI2000Magellan Autologous Platelet Separator SystemBTI200BTI2002016-09-09
M896CLPTPK1010CP Disposable KitCLPT-PK-101CLPT-PK-1012018-12-12
M896CLPTPK101450Cellpoint CP Disposable Kit with 45mm Lightning NeedleCLPT-PK-101-45CLPT-PK-101-452020-02-26
M896IBIA55600Small Anchor Awl 5mmIB-IA-5560IB-IA-55602022-12-19
M896IBIA65700Medium Anchor Awl 6mmIB-IA-6570IB-IA-65702022-12-19
M896IBIA75800Large Anchor Awl 7mmIB-IA-7580IB-IA-75802022-12-19
M896IBIA85900Xlarge Anchor Awl 8mmIB-IA-8590IB-IA-85902022-12-19
M896IBK00010Fibrant Instrument Kit IB-K-0001IB-K-00012022-12-19
M896IQSPMX1500InQu Matrix 5x10cmIQSP-MX-150IQSP-MX-1502022-06-23
M896IQSPPP1010InQu Paste Mix Plus 1.25ccIQSP-PP-101IQSP-PP-1012018-08-01
M896IQSPPP1020InQu Paste Mix Plus 2.5ccIQSP-PP-102IQSP-PP-1022018-08-01
M896IQSPPP1050InQu Paste Mix Plus 5ccIQSP-PP-105IQSP-PP-1052018-08-01
M896IQSPPP1100InQu Paste Mix Plus 10ccIQSP-PP-110IQSP-PP-1102018-08-01
M896MAG1000Magellan Autologous Platelet Separator SystemMAG100MAG1002016-09-09
M896MAG2000Magellan Autologous Platelet Separator SystemMAG200MAG2002016-09-09
M896MAR0MAX450Magellan MAR0Max QuickDraw Convenience KitMAR0Max45MAR0Max452016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800025901601BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901854BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
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