PROstep™ TBC
GUDID 00889797073103
WRIGHT MEDICAL TECHNOLOGY, INC.
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00889797073103 |
| NIH Device Record Key | 7f6edd41-dcbc-4a5d-b345-ede40b4d266d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROstep™ TBC |
| Version Model Number | 97700000 |
| 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 | 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 |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889797073103 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183620
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-01 |
| Device Publish Date | 2019-10-24 |
On-Brand Devices [PROstep™ TBC]
| 00889797073271 | 97700017 |
| 00889797073264 | 97700016 |
| 00889797073257 | 97700015 |
| 00889797073240 | 97700014 |
| 00889797073233 | 97700013 |
| 00889797073226 | 97700012 |
| 00889797073219 | 97700011 |
| 00889797073202 | 97700010 |
| 00889797073196 | 97700009 |
| 00889797073172 | 97700007 |
| 00889797073165 | 97700006 |
| 00889797073158 | 97700005 |
| 00889797073141 | 97700004 |
| 00889797073134 | 97700003 |
| 00889797073127 | 97700002 |
| 00889797073110 | 97700001 |
| 00889797073103 | 97700000 |
| 00889797100113 | Broach |
| 00889797100106 | Broach |
| 00889797100090 | Broach |
| 00889797100083 | Broach |
| 00889797100076 | Broach |
| 00889797100069 | Broach |
| 00889797100052 | Hex Driver |
| 00889797100021 | Steinmann Pin |
| 00889797100014 | Shelf Drill |
Trademark Results [PROstep]
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