CER-ORTHO-M CER-ORTHO-M

GUDID 10850023741483

CER-ORTHO-M NEEDLE, F/G, STERILE PN: 74399-01M

RANFAC CORP.

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• Primary Device ID: 10850023741483
• NIH Device Record Key: 825ab0c4-c2c9-4a12-9a41-82a0e47db3e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CER-ORTHO-M
• Version Model Number: 11 GA X 11.4 CM
• Catalog Number: CER-ORTHO-M
• 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
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com

Device Dimensions

• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter
• Needle Gauge: 11 Gauge
• Length: 11.4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850023741486 [Primary]
GS1	10850023741483 [Package]; Contains: 00850023741486; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20850023741480 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-18
• Device Publish Date: 2021-11-10

On-Brand Devices [CER-ORTHO-M]

• 10850023741155: CER-ORTHO-M, F/G, STERILE P/N 74376-01M
• 10850023741483: CER-ORTHO-M NEEDLE, F/G, STERILE PN: 74399-01M