FlareHawk II-1-0239

GUDID 00850231007718

Cup Curette - 4mm x 10mm Oval - Angled 15 degrees

INTEGRITY IMPLANTS INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00850231007718
• NIH Device Record Key: a0897f3c-f152-4f22-aff9-9ee8cd3578a5
• Commercial Distribution Discontinuation: 2018-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FlareHawk
• Version Model Number: II-1-0239
• Catalog Number: II-1-0239
• Company DUNS: 080300717
• Company Name: INTEGRITY IMPLANTS 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com
• Phone: 8002019300
• Email: singlese@integrityimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850231007718 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

[00850231007718]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2017-01-30

On-Brand Devices [FlareHawk]

• 00818613020960: Guide Pin, Gun Inserter
• 00818613020953: Gun Inserter, Long
• 00818613020786: Split Shim, 12 mm or 14 mm x 23 mm, 6 degree
• 00818613020779: Split Shim, 11 mm or 13 mm x 23 mm, 6 degree
• 00818613020762: Split Shim, 10 mm or 12 mm x 23 mm, 6 degree
• 00818613020755: Split Shim, 11 mm or 14 mm x 23 mm, 0 degree
• 00818613020748: Split Shim, 10 mm or 13 mm x 23 mm, 0 degree
• 00818613020731: Split Shim, 9 mm or 12 mm x 23 mm, 0 degree
• 00818613020724: Split Shim, 8 mm or 11 mm x 23 mm, 0 degree
• 00818613020717: Shell, Tall 23mm, Split Shim
• 00818613020700: Shell, Short 23mm, Split Shim
• 00818613020694: 12 mm or 14 mm x 27 mm, 6 degree, Split Shim
• 00818613020687: 11 mm or 13 mm x 27 mm, 6 degree, Split Shim
• 00818613020670: 10 mm or 12 mm x 27 mm, 6 degree, Split Shim
• 00818613020663: 11 mm or 14 mm x 27 mm, 0 degree, Split Shim
• 00818613020656: 10 mm or 13 mm x 27 mm, 0 degree, Split Shim
• 00818613020649: 9 mm or 12 mm x 27 mm, 0 degree, Split Shim
• 00818613020632: 8 mm or 11 mm x 27 mm, 0 degree, Split Shim
• 00818613020625: Shell, Tall 27mm, Split Shim
• 00818613020618: Shell, Short 27mm, Split Shim
• 00818613020090: Cannula Assembly 23mm
• 00850231007978: 15mm Paddle Distractor
• 00850231007886: 6mm Distractor
• 00850231007879: Shell Assembly Tall 23mm Version B
• 00850231007862: 10mm or 12mm x 33mm Version B, 6 degree – Shim
• 00850231007787: Expandable Guide
• 00850231007770: Cup Curette - 4mm x 10mm Oval - Straight
• 00850231007756: Uterine Curette - 11mm x 4mm
• 00850231007749: 8mm x 20mm - Angled 15 degrees
• 00850231007732: 6mm Round - Angled 15 degrees
• 00850231007718: Cup Curette - 4mm x 10mm Oval - Angled 15 degrees
• 00850231007701: Cup Curette - 4mm x 8mm Oval - Angled 15 degrees
• 00850231007695: Cup Curette - 4mm x 6mm Oval - Angled 15 degrees
• 00850231007688: Cup Curette - 4mm x 6mm Oval - Straight
• 00850231007671: Rasp - 12mm x 30mm Rectangular Angled 15 degrees
• 00850231007664: Osteotome - 15mm Wide
• 00850231007657: 25mm Cobb Elevator
• 00850231007640: 20mm Cobb Elevator
• 00850231007633: Shell Assembly Tall 33mm Version B
• 00850231007626: Shell Assembly Short 33mm Version B
• 00850231007619: 12mm or 14mm x 33mm Version B, 6 degree – Shim
• 00850231007602: 11mm or 13mm x 33mm Version B, 6 degree – Shim
• 00850231007596: 11mm or 14mm x 33mm Version B, 0 degree – Shim
• 00850231007589: 10mm or 13mm x 33mm Version B, 0 degree – Shim
• 00850231007572: 9mm or 12mm x 33mm Version B, 0 degree – Shim
• 00850231007565: 8mm or 11mm x 33mm Version B, 0 degree – Shim
• 00850231007558: Shell Assembly Short 23mm Version B
• 00850231007541: 12mm or 14mm x 23mm Version B, 6 degree – Shim
• 00850231007534: 11mm or 13mm x 23mm Version B, 6 degree – Shim
• 00850231007527: 10mm or 12mm x 23mm Version B, 6 degree – Shim