MAXX-REGEN RB-REG-3

GUDID 20857878007037

MAXX-REGEN Bone Marrow Aspirate Kit w/ Bone Harvester 11GA X 11CM MC-RAN-11CSTS 8GA X 10CM RJN-810 Customer # 0018407 PN 74292-03M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 20857878007037
• NIH Device Record Key: f1b6a6bd-d701-4f21-b7c3-5c8c89ccae4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX-REGEN
• Version Model Number: 11GA X 11CM
• Catalog Number: RB-REG-3
• 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: 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

Customer Support Contacts

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

Device Dimensions

• Needle Gauge: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857878007033 [Primary]
GS1	10857878007030 [Package]; Contains: 00857878007033; Package: Inner [1 Units]; In Commercial Distribution
GS1	20857878007037 [Package]; Contains: 10857878007030; Package: Case [30 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: 2019-06-25
• Device Publish Date: 2019-06-17

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