CER-ORTHO-M CER-ORTHO-M

GUDID 10850023741155

CER-ORTHO-M, F/G, STERILE P/N 74376-01M

RANFAC CORP.

Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula

• Primary Device ID: 10850023741155
• NIH Device Record Key: 5cd2cde0-b3b7-443a-9f43-1d808bfa7327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CER-ORTHO-M
• Version Model Number: 11 Gauge x 6.1CM
• 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

Device Dimensions

• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850023741158 [Primary]
GS1	10850023741155 [Package]; Contains: 00850023741158; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20850023741152 [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: 2021-04-15
• Device Publish Date: 2021-04-07

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