NEEDLE, RAN-815N, RAN-815N

GUDID 20858690006758

NEEDLE, RAN-815N PN 74174-15M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 20858690006758
• NIH Device Record Key: c58197e7-1e40-4294-ac6f-a65d64826576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEEDLE, RAN-815N,
• Version Model Number: 8 GAUGE X 150MM
• Catalog Number: RAN-815N
• 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: 150 Millimeter
• Length: 150 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006754 [Primary]
GS1	10858690006751 [Package]; Contains: 00858690006754; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20858690006758 [Package]; Contains: 10858690006751; 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

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• 10850023741865 - CER-BN-84-SCR: 2024-01-08 CER-BN-84-SCR, F/G, STERILE, P/N 74432-01M
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• 10850023741803 - RAN-1528: 2023-11-28 NEEDLE, RAN-1528, F/G, STERILE, RANFAC P/N 74421-01M
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