MIELO-CAN MCN04

GUDID 18033959220471

=Bone marrow biopsy needle, 14G, 40-58 mm; max 78 mm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959220471
• NIH Device Record Key: 5562aeb4-1856-4864-baa1-914e37394fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIELO-CAN
• Version Model Number: MIELO-CAN
• Catalog Number: MCN04
• Company DUNS: 439659574
• Company Name: STERYLAB SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 14 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033959220474 [Primary]
GS1	18033959220471 [Package]; Contains: 08033959220474; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

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: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [MIELO-CAN]

• 18033959224981: Bone marrow biopsy needle, 14G, 10-28 mm; max 48 mm
• 18033959220471: =Bone marrow biopsy needle, 14G, 40-58 mm; max 78 mm
• 18033959220464: Bone marrow biopsy needle, 15G, 10-28 mm; max 48 mm
• 18033959220457: Bone marrow biopsy needle, 15G, 22-40 mm; max 60 mm
• 18033959220440: Bone marrow biopsy needle, 15G, 10-28 mm; max 48 mm
• 18033959220433: Bone marrow biopsy needle, 18G, 10-28 mm; max 48 mm