| Primary Device ID | 00885556830642 |
| NIH Device Record Key | 7c980ca7-d8bb-4a05-85db-1a311e27b51e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PyroSphere CMC |
| Version Model Number | BRH-445-10 |
| Catalog Number | BRH-445-10 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556830642 [Primary] |
| HTT | BURR, ORTHOPEDIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
[00885556830642]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 00885556830734 | PCS IMPLANT EXTRACTOR |
| 00885556830680 | SPHERICAL BURR SZ. 50 |
| 00885556830673 | SPHERICAL BURR SZ. 40 |
| 00885556830666 | SPHERICAL BURR SZ. 30 |
| 00885556830659 | SPHERICAL BURR SZ. 20 |
| 00885556830642 | SPHERICAL BURR SZ. 10 |
| 00885556830741 | PCS SZ. 10 PYROSPHERE |
| 00885556830758 | PCS SZ. 20 PYROSPHERE |
| 00885556830772 | PCS SZ. 40 PYROSPHERE |
| 00885556830765 | PCS SZ. 30 PYROSPHERE |
| 00885556830888 | PYROSPHERE TRIAL SZ. 50 |
| 00885556830871 | PYROSPHERE TRIAL SZ. 40 |
| 00885556830864 | PYROSPHERE TRIAL SZ. 30 |
| 00885556830857 | PYROSPHERE TRIAL SZ. 20 |
| 00885556830840 | PYROSPHERE TRIAL SZ. 10 |
| 00885556830789 | PCS SZ. 50 PYROSPHERE |
| 00885556830727 | PHS CASE LID |
| 00885556830710 | PHS CASE |
| 00885556830703 | PCS INSTRUMENT CASE BASE |
| 00885556830697 | PCS INSTRUMENT CASE LID |