MC-RAN-11C RB-REG-1

GUDID 00858690006211

MC-RAN-11C-MAXX REGEN PN 74292-01M Customer# 0018407

RANFAC CORP.

Bone access cannula

• Primary Device ID: 00858690006211
• NIH Device Record Key: a02e7a39-8dad-4c72-bffd-ae636e0dfe14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MC-RAN-11C
• Version Model Number: 11GA X 9CM
• Catalog Number: RB-REG-1
• 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: 9 Centimeter
• Length: 9 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006211 [Primary]
GS1	10858690006218 [Package]; Package: Inner pack [1 Units]; In Commercial Distribution
GS1	20858690006215 [Package]; Contains: 10858690006218; 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-11C]

• 00858690006211: MC-RAN-11C-MAXX REGEN PN 74292-01M Customer# 0018407
• 10858690006140: MC-RAN-11C F/G, STERILE P/N 74278-01M