NEEDLE, RAN-815NRT-BEV, SF, F/G RAN-815NRT-BEV

GUDID 20858690006697

NEEDLE, RAN-815NRT-BEV, SF, F/G PN 74174-01M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 20858690006697
• NIH Device Record Key: 778b2dfb-3ec9-4985-b4a6-2b79150d8fe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEEDLE, RAN-815NRT-BEV, SF, F/G
• Version Model Number: 8 GAUGE x 150MM
• Catalog Number: RAN-815NRT-BEV
• 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: 8 Gauge
• Needle Gauge: 8 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006693 [Primary]
GS1	10858690006690 [Package]; Contains: 00858690006693; Package: Inner pack [1 Units]; In Commercial Distribution
GS1	20858690006697 [Package]; Contains: 10858690006690; Package: Case [10 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: 2017-05-01

Devices Manufactured by RANFAC CORP.

• 10850023741940 - MC-RAN-BZL-8C: 2024-04-12 MC-RAN-BZL-8C F/G, STERILE, P/N 74438-01M
• 10850023741919 - Cervos Platelet Separator Triple Pack ACDA: 2024-04-10 CER-PRP-TRIPLE-A F/G, STERILE PN: 76148-01M
• 10850023741902 - MC-RAN-BZL: 2024-03-27 MC-RAN-BZL F/G, STERILE, P/N 74436-01M
• 10850023741889 - Bone Marrow Biopsy Needle, RBN-114-BS: 2024-03-21 Bone Marrow Biopsy Needle, RBN-114-BS PN 74434-01M
• 10850023741865 - CER-BN-84-SCR: 2024-01-08 CER-BN-84-SCR, F/G, STERILE, P/N 74432-01M
• 00850023741875 - CER-SUB-1590: 2023-12-21 CER-SUB-1590, F/G, STERILE, P/N 74433-01M
• 10850023741803 - RAN-1528: 2023-11-28 NEEDLE, RAN-1528, F/G, STERILE, RANFAC P/N 74421-01M
• 10850023741810 - RBN-133: 2023-11-28 NEEDLE, RBN-133, F/G, STERILE, RANFAC P/N 74425-01M