| Primary Device ID | M724CCB531 |
| NIH Device Record Key | a8925944-48eb-4936-9743-80fcd003ce5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ContourFlex™ Gluteal Implant, Round |
| Version Model Number | Size 3 |
| Catalog Number | CCB5-3 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M724CCB531 [Primary] |
| MIB | Elastomer, Silicone Block |
| 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 | 2015-09-24 |
| M724CCB5K21 | Contoured Carving Block Implant |
| M724CCB541 | Contoured Carving Block Implant |
| M724CCB531 | Contoured Carving Block Implant |
| M724CCB521 | Contoured Carving Block Implant |
| M724CCB511 | Contoured Carving Block Implant |
| M724CCB501 | Contoured Carving Block Implant |
| M724CCB5K11 | Contoured Carving Block Implant |
| M724CCB571 | Contoured Carving Block Implant |
| M724CCB561 | Contoured Carving Block Implant |
| M724CCB551 | Countoured Carving Block Implant |