IGNITE
GUDID 00840420135155
WRIGHT MEDICAL TECHNOLOGY, INC.
Bone matrix implant, synthetic| Primary Device ID | 00840420135155 |
| NIH Device Record Key | bc4669e3-6367-4b1b-a45c-2c54090e795c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IGNITE |
| Version Model Number | 876P2000 |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, 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 | true |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420135155 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052913
FDA Product Code
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [IGNITE]
| 00840420135162 | 876P0400 |
| 00840420135155 | 876P2000 |
| 00840420133694 | 860D2000 |
Trademark Results [IGNITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IGNITE 98853012 not registered Live/Pending |
Grow Source LLC 2024-11-14 |
 IGNITE 98841239 not registered Live/Pending |
The West Nottingham Academy in Cecil County 2024-11-07 |
 IGNITE 98700515 not registered Live/Pending |
Service Management Group, LLC 2024-08-15 |
 IGNITE 98477101 not registered Live/Pending |
Alcon Inc. 2024-04-01 |
 IGNITE 98278502 not registered Live/Pending |
Sioux Center Chamber of Commerce 2023-11-20 |
 IGNITE 98278286 not registered Live/Pending |
Sioux Center Chamber of Commerce 2023-11-20 |
 IGNITE 98217346 not registered Live/Pending |
IGNITE INTERNATIONAL, LTD 2023-10-10 |
 IGNITE 98148312 not registered Live/Pending |
ARISTOCRAT TECHNOLOGIES AUSTRALIA PTY LTD 2023-08-24 |
 IGNITE 98100706 not registered Live/Pending |
LIVEREZ, LLC 2023-07-25 |
 IGNITE 97978304 not registered Live/Pending |
DOOSAN BOBCAT NORTH AMERICA INC. 2022-09-13 |
 IGNITE 97899020 not registered Live/Pending |
Hatch, Inc. 2023-04-20 |
 IGNITE 97822110 not registered Live/Pending |
Live Nation Entertainment, Inc. 2023-03-03 |
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