| Primary Device ID | M724BNPI3T1R1 |
| NIH Device Record Key | e18732d0-d38c-4059-9533-1f3e0b2450c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerflex™ Pectoral Implant, Novack Style 3, SDM |
| Version Model Number | Size: 1, Right Side |
| Catalog Number | BNPI3-T-1R |
| Company DUNS | 784664955 |
| Company Name | IMPLANTECH ASSOCIATES, 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 |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com | |
| Phone | 1-800-733-0833 |
| info@implantech.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M724BNPI3T1R1 [Primary] |
| MIC | Implant, Muscle, Pectoralis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2017-08-08 |
| M724BNPI3T1R1 | Pectoral Implant |
| M724BNPI3T1L1 | Pectoral Implant |