Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM MC-RAN-13FA

GUDID 20857878007082

Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM

RANFAC CORP.

Bone marrow biopsy procedure kit

• Primary Device ID: 20857878007082
• NIH Device Record Key: f5c6b07c-00e1-40b9-986d-83a26968b952
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ranfac Marrow Cellution Aspiration Needle 13GA X 5CM
• Version Model Number: 13GA X 5CM
• Catalog Number: MC-RAN-13FA
• 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: true
• 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: 13 Gauge
• Needle Gauge: 13 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857878007088 [Primary]
GS1	10857878007085 [Package]; Contains: 00857878007088; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20857878007082 [Package]; Contains: 10857878007085; Package: Case [10 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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-07

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