Maxx Cell MXC-2

GUDID 00857878007453

MC-RAN-11CSTS MAXX CELL WITH PREPARATION ACCESSORIES PN 74317-02M Customer# 0018407

RANFAC CORP.

Bone marrow biopsy procedure kit

• Primary Device ID: 00857878007453
• NIH Device Record Key: 26d5d1a5-bed1-431f-a868-4418c1664b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxx Cell
• Version Model Number: 11GA X 11CM
• Catalog Number: MXC-2
• Company DUNS: 121622872
• Company Name: RANFAC CORP.
• 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: true
• 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

Customer Support Contacts

• Phone: 5085884400
• Email: info@ranfac.com

Device Dimensions

• Needle Gauge: 11 Gauge
• Needle Gauge: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857878007453 [Primary]
GS1	10857878007450 [Package]; Package: Inner [1 Units]; In Commercial Distribution
GS1	20857878007457 [Package]; Contains: 10857878007450; Package: Case [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150563

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: 2018-09-13
• Device Publish Date: 2018-08-13

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