ALLOMATRIX
GUDID 00840420149220
WRIGHT MEDICAL TECHNOLOGY, INC.
Bone matrix implant, human-derived| Primary Device ID | 00840420149220 |
| NIH Device Record Key | bb713233-d9f2-4e79-82b1-e0fd9fea2c65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALLOMATRIX |
| Version Model Number | 86CP0300 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 3 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420149220 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041663
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 [ALLOMATRIX]
| 00840420149220 | 86CP0300 |
| 00840420134943 | 86CP1200 |
| 00840420134882 | 86000050 |
| 00840420134707 | 86CP0700 |
| 00840420133588 | 86002000 |
| 00840420133571 | 86001000 |
| 00840420133564 | 86000500 |
| 00840420133557 | 86000100 |
| 00840420133540 | 860C2000 |
| 00840420133533 | 860C1000 |
| 00840420133526 | 860C0500 |
| 00840420133519 | 86XC1000 |
| 00840420133502 | 86XC0500 |
| 00840420133496 | 86DR0300 |
Trademark Results [ALLOMATRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLOMATRIX 75679251 2553209 Live/Registered |
Wright Medical Technology, Inc. 1999-04-12 |
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