Paragon 28
GUDID B504OMP9910020140
Provision
Drilling power tool attachment, basic| Primary Device ID | B504OMP9910020140 |
| NIH Device Record Key | 52b012e4-6138-4f00-becd-cf365fbfaf44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paragon 28 |
| Version Model Number | P99-100-2014 |
| Company DUNS | 016889401 |
| Company Name | Provision |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com | |
| Phone | 541-480-7953 |
| customersupport@provisiondrs.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B504OMP9910020140 [Primary] |
FDA Product Code
| HTW | Bit, Drill |
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 | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
On-Brand Devices [Paragon 28]
Trademark Results [Paragon 28]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PARAGON 28 86237529 4810921 Live/Registered |
Paragon 28, Inc. 2014-03-31 |
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