Primary Device ID | 00850231007435 |
NIH Device Record Key | 8928d9ee-f80a-4bae-8822-93ddfc6c65a8 |
Commercial Distribution Discontinuation | 2020-05-07 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | FlareHawk |
Version Model Number | II-1-0167 |
Catalog Number | FHTA-S1-06-27-B |
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 | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com | |
Phone | 8002019300 |
customerservice@integrityimplants.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850231007435 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
[00850231007435]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-05-08 |
Device Publish Date | 2017-01-30 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FLAREHAWK 86930759 5205928 Live/Registered |
Integrity Implants Inc. 2016-03-07 |