| Primary Device ID | 00850005618102 |
| NIH Device Record Key | 89e7b028-90c1-49fe-b863-03eeff391aa9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioPoly® Lesser Toe Hemiarthroplasty Implant |
| Version Model Number | 130-5109 |
| Catalog Number | 130-5109 |
| Company DUNS | 023778928 |
| Company Name | Biopoly, LLC |
| 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 | false |
| 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 |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005618102 [Primary] |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
| 00850005618140 | BioPoly® Lesser Toe Hemiarthroplasty Implant - 13mm Porous |
| 00850005618133 | BioPoly® Lesser Toe Hemiarthroplasty Implant - 12mm Porous |
| 00850005618126 | BioPoly® Lesser Toe Hemiarthroplasty Implant - 11mm Porous |
| 00850005618119 | BioPoly® Lesser Toe Hemiarthroplasty Implant - 10mm Porous |
| 00850005618102 | BioPoly® Lesser Toe Hemiarthroplasty Implant - 9mm Porous |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOPOLY 86204584 4620416 Live/Registered |
BIOPOLY, LLC 2014-02-26 |
![]() BIOPOLY 77932427 3852948 Live/Registered |
BioPoly LLC 2010-02-10 |