RAN-8 RAN-8

GUDID 20857878007778

RAN-8, SF, F/G, STERILE, RANFAC P/N 74171-11M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 20857878007778
• NIH Device Record Key: d160d7d4-3d29-4561-b0d5-a931d6526c25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAN-8
• Version Model Number: 8GA X 11CM
• Catalog Number: RAN-8
• 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: 11 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857878007774 [Primary]
GS1	10857878007771 [Package]; Contains: 00857878007774; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	20857878007778 [Package]; Contains: 10857878007771; 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: 2019-05-08
• Device Publish Date: 2019-04-30

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