W-Bone

GUDID 05430001477108

W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.

Wishbone

Dental bone matrix implant, animal-derived

• Primary Device ID: 05430001477108
• NIH Device Record Key: de0e24e5-9b0f-4e28-a560-fb2d097d6145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: W-Bone
• Version Model Number: WHA100
• Company DUNS: 370488802
• Company Name: Wishbone
• 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: true
• 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: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com
• Phone: +3242865066
• Email: info@wishbone-biotech.com

Device Dimensions

• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430001477108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211551

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

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: 2024-09-20
• Device Publish Date: 2024-09-12

On-Brand Devices [W-Bone]

• 05430001477115: W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended
• 05430001477108: W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended
• 05430001477092: W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended
• 05430001477085: W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended