MC-RAN-11CSTS RB-REG-2

GUDID 00858690006228

MC-RAN-11CSTS MAXX-REGEN Customer # 0018407 PN 74292-02M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 00858690006228
• NIH Device Record Key: e36dc3cd-2949-403d-95c4-ffd8e34866a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC-RAN-11CSTS
• Version Model Number: 11GA X 11CM
• Catalog Number: RB-REG-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: 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
• Needle Gauge: 11 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006228 [Primary]
GS1	10858690006225 [Package]; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20858690006222 [Package]; Contains: 10858690006225; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-09

On-Brand Devices [MC-RAN-11CSTS]

• 00858690006228: MC-RAN-11CSTS MAXX-REGEN Customer # 0018407 PN 74292-02M
• 10858690006157: MC-RAN-11CSTS F/G, STERILE P/N 74278-02M