Lightning Needle

GUDID M896LTN25O1

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Bone marrow biopsy needle, single-use

• Primary Device ID: M896LTN25O1
• NIH Device Record Key: 32c5ea1c-02bd-4f74-b152-066a0ec27d5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightning Needle
• Version Model Number: LTN25-O
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896LTN25O0 [Primary]
HIBCC	M896LTN25O1 [Package]; Contains: M896LTN25O0; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141910

FDA Product Code

• FCG: Biopsy Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-01
• Device Publish Date: 2019-03-23

On-Brand Devices [Lightning Needle]

• M896LTN45O1: LTN45-O
• M896LTN25O1: LTN25-O
• M896LTN105O1: LTN105-O