MAXX-CELL BM-MXC-3

GUDID 00857878007828

MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 10CM RJN-810 PN 74340-03M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 00857878007828
• NIH Device Record Key: 8cc56f13-ccf1-4f62-9b01-d4d5405d1a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX-CELL
• Version Model Number: 11GA X 11CM
• Catalog Number: BM-MXC-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

• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857878007828 [Primary]
GS1	10857878007825 [Package]; Package: Inner [1 Units]; In Commercial Distribution
GS1	20857878007822 [Package]; Contains: 10857878007825; 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: 2019-09-02
• Device Publish Date: 2019-08-23

On-Brand Devices [MAXX-CELL]

• 20857878007358: Maxx-Cell Bone Marrow Aspiration Kit Customer # 0018407 PN 74317-07M
• 00857878007828: MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 10CM RJN-8