| Primary Device ID | 00885556866030 |
| NIH Device Record Key | 1c50f8cf-6ad0-40fb-9b75-5e847654687f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Subtalar MBA Implant System |
| Version Model Number | 051020 |
| Catalog Number | 051020 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556866030 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
[00885556866030]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| 00885556866047 | MBA TRAY STERILIZATION CASE |
| 00885556866030 | DRIVER FOR TITANIUM MBA ONLY 3.5MM HRX |
| 00885556866023 | 12MM SIZER |
| 00885556866016 | 10MM SIZER |
| 00885556866009 | 9MM SIZER |
| 00885556865996 | 8MM SIZER |
| 00885556865989 | 6MM SIZER |
| 00885556865972 | PROBE |
| 00885556821671 | COMBO DRIVER |
| 00885556865910 | SUBTALAR MBA IMPLANT. 12MM |
| 00885556865903 | SUBTALAR MBA IMPLANT. 10MM |
| 00885556865897 | SUBTALAR MBA IMPLANT. 9MM |
| 00885556865880 | SUBTALAR MBA IMPLANT. 8MM |
| 00885556865873 | SUBTALAR MBA IMPLANT. 6MM |