RAN-11 RAN-11

GUDID 00857878007873

RAN-11, F/G, STERILE CE MARKED P/N: 74062-02M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 00857878007873
• NIH Device Record Key: 7ea76a55-011d-4c86-a44f-527f08b743c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAN-11
• Version Model Number: 11Ga X 11cm
• Catalog Number: RAN-11
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857878007873 [Primary]
GS1	10857878007870 [Package]; Package: BOX [10 Units]; In Commercial Distribution
GS1	20857878007877 [Package]; Contains: 10857878007870; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131157

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: 2019-09-12
• Device Publish Date: 2019-09-04

On-Brand Devices [RAN-11]

• 00857878007873: RAN-11, F/G, STERILE CE MARKED P/N: 74062-02M
• 10850023741407: RAN-11 PN: 74195-01M
• 10858690006393: RAN-11 BLUE F/G, STERILE, K2M P/N 74192-01M