PRO-STIM
GUDID 00840420143150
WRIGHT MEDICAL TECHNOLOGY, INC.
Bone matrix implant, synthetic| Primary Device ID | 00840420143150 |
| NIH Device Record Key | 80a8a04a-cb4d-43b6-be51-8c69e9546ad1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRO-STIM |
| Version Model Number | 86SR0420 |
| 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 | |
| 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 |
| Total Volume | 20 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| 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 | 00840420143150 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083270
FDA Product Code
| MBP | Filler, bone void, osteoinduction (w/o human growth factor) |
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 [PRO-STIM]
| 00840420143167 | 86SRCK15 |
| 00840420143150 | 86SR0420 |
| 00840420143143 | 86SR0410 |
| 00840420143136 | 86SR0404 |
Trademark Results [PRO-STIM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-STIM 77659910 3865170 Live/Registered |
Wright Medical Technology, Inc. 2009-01-30 |
 PRO-STIM 75623678 2370329 Dead/Cancelled |
BRONSON LABORATORIES, INC. 1999-01-20 |
 PRO-STIM 74189690 1703068 Dead/Cancelled |
KANARE ORGANIZATION, INC., THE 1991-07-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.