MIELO-CAN ILIAC MCN04I

GUDID 18033959228231

Iliac crest bone-marrow explantation needle 14G; 8 cm

STERYLAB SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 18033959228231
• NIH Device Record Key: dd0726ba-917c-479a-b908-0a08e098d18d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIELO-CAN ILIAC
• Version Model Number: MIELO-CAN ILIAC
• Catalog Number: MCN04I
• 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	08033959228234 [Primary]
GS1	18033959228231 [Package]; Contains: 08033959228234; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

FDA Product Code

• KNW: Instrument, Biopsy

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 ILIAC]

• 18033959228248: Iliac crest bone-marrow explantation needle 13G; 10 cm
• 18033959228231: Iliac crest bone-marrow explantation needle 14G; 8 cm
• 18033959228224: Iliac crest bone-marrow aspiration needle 15G; 6 cm