RANR-1115N5T RANR-1115N5T

GUDID 20857878007013

RANR-1115N5T PN 74189-15M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 20857878007013
• NIH Device Record Key: f1a0bbeb-51d5-4bb0-b4b2-d8d3c67b227d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RANR-1115N5T
• Version Model Number: 11 GA x 150MM
• Catalog Number: RANR-1115N5T
• 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	00857878007019 [Primary]
GS1	10857878007016 [Package]; Contains: 00857878007019; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	20857878007013 [Package]; Contains: 10857878007016; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-07

Devices Manufactured by RANFAC CORP.

• 10850023741995 - CER-SUB-1590 CE: 2024-10-25 CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M
• 10850023741988 - Cervos Platelet Single B: 2024-09-18 CER-PRP-SINGLE-B F/G, STERILE PN: 76133-01M
• 10857878007313 - MAXX-CELL-3: 2024-09-17 MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 15CM RJN-815 PN 74408-01M
• 10850023741964 - BANRAN-11: 2024-07-18 BANRAN-11, F/G, STERILE, P/N 76153-01M
• 10850023741896 - CER-PRP-JUVA: 2024-05-23 CER-PRP-JUVA F/G, STERILE PN: 76145-01M
• 00850023741929 - CER-JUVA-BD ASSEMBLY: 2024-05-23 CER-JUVA-BD Assembly PN 69014-01M
• 00850023741936 - CER-PRP-JUVA-KIT: 2024-05-23 CER-PRP-JUVA-KIT F/G, STERILE PN: 76152-01M
• 10850023741957 - MC-RAN-BZL-8C: 2024-05-14 MC-RAN-BZL-8C F/G, STERILE, P/N 74431-01M