Biopor® CSP-0019

GUDID CSP00190

Orbiral Spheres - AOC Coated - ø19mm

CEREMED, INC.

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: CSP00190
• NIH Device Record Key: a841e6d2-e66f-4b5c-8b04-c523ec352058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopor®
• Version Model Number: CSP-0019
• Catalog Number: CSP-0019
• Company DUNS: 626959824
• Company Name: CEREMED, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 310-815-2125
• Email: info@ceremed.com
• Phone: 310-815-2125
• Email: info@ceremed.com

Device Dimensions

• Outer Diameter: 19 Millimeter
• Outer Diameter: 19 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	CSP00190 [Primary]

FDA Product Code

• KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-20

On-Brand Devices [Biopor®]

• CSR50520: Large Malar Shell R
• CSR40520: Medium Malar Shell R
• CSR30520: Small Malar Shell R
• CSP00220: Orbiral Spheres - AOC Coated - ø22mm
• CSP00210: Orbiral Spheres - AOC Coated - ø21mm
• CSP00200: Orbiral Spheres - AOC Coated - ø20mm
• CSP00190: Orbiral Spheres - AOC Coated - ø19mm
• CSP00180: Orbiral Spheres - AOC Coated - ø18mm
• CSP00160: Orbiral Spheres - AOC Coated - ø16mm
• CSL50520: Large Malar Shell L
• CSL40520: Medium Malar Shell L
• CSL30520: Small Malar Shell L
• CSH30580: Sheet 3 x 50 x 80 mm
• CSH30540: Sheet 3 x 50 x 40 mm
• CSH15580: Sheet 1.5 x 50 x 80 mm
• CSH15540: Sheet 1.5 x 50 x 40 mm
• CSH08580: Sheet 0.80 x 50 x 80 mm
• CSH08540: Sheet 0.80 x 50 x 40 mm
• CSH05580: Sheet 0.45 x 50 x 80 mm
• CSH05540: Sheet 0.45 x 50 x 40 mm
• CMR60520: Large Malar Right
• CMR45520: Medium Malar Right
• CMR30520: Small Malar Right
• CML60520: Large Malar Left
• CML45520: Medium Malar Left
• CML30520: Small Malar Left
• CCS90640: Large Square Chin
• CCS60640: Medium Square Chin
• CCS40640: Small Square Chin
• CCR90640: Large Round Chin
• CCR60640: Medium Round Chin
• CCR40640: Small Round Chin