PRO-DENSE™
GUDID 00889797072724
WRIGHT MEDICAL TECHNOLOGY, INC.
Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | 00889797072724 |
| NIH Device Record Key | 91e62e4c-dec7-4344-8b87-270c753cb8ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO-DENSE™ |
| Version Model Number | 87SRCDK0 |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | +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
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889797072724 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181255
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-16 |
| Device Publish Date | 2020-09-08 |
On-Brand Devices [PRO-DENSE™]
| 00889797072731 | 1200SYR0 |
| 00889797073318 | 87SR0120 |
| 00889797073301 | 87SR0070 |
| 00889797072762 | 87SR0100 |
| 00889797072755 | 87SR0050 |
| 00889797072748 | 87SR0020 |
| 00889797072724 | 87SRCDK0 |
| 00889797072717 | 87SR0400 |
| 00889797072700 | 87SR0150 |
Trademark Results [PRO-DENSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-DENSE 78956507 3350402 Live/Registered |
Wright Medical Technology, inc. 2006-08-21 |
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