| Primary Device ID | 00885556021644 |
| NIH Device Record Key | 354b91aa-9f3c-4ec6-a7b9-57219094ef11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOLOX FORTE CERAMIC |
| Version Model Number | 71330328 |
| Catalog Number | 71330328 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | 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 | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | 1-800-238-7538 |
| GUDID@SMITH-NEPHEW.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556021644 [Primary] |
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-04-30 |
| 00885556021644 | BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +8 |
| 00885556021248 | BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +4 |
| 00885556020869 | BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +0 |
| 00885556020838 | BIOLOX FORTE CERAMIC 28MM FEM HEAD 12/14 TAPER +0 |
| 00885556020531 | BIOLOX FORTE US FEMORAL HEAD 36MM L/+8 12/14 TPR |
| 00885556020241 | BIOLOX FORTE US FEMORAL HEAD 36MM M+4 12/14 TPR +4 |
| 00885556019993 | BIOLOX FORTE CERAMIC 28MM FEMORAL HEAD 12/14 TPR +8 |
| 00885556019849 | BIOLOX FORTE US FEMORAL HEAD 36MM S/+0 12/14 TPR |
| 00885556019726 | BIOLOX FORTE CERAMIC 28MM FEM HEAD 12/14 TAPER +4 |