| Primary Device ID | 00885556921456 |
| NIH Device Record Key | 41a9be62-d3eb-4096-a31d-938f4c712362 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R3 |
| Version Model Number | E0018306-1 |
| Catalog Number | E0018306-1 |
| Company DUNS | 045483575 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556921456 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
[00885556921456]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-04 |
| Device Publish Date | 2024-11-26 |
| 00885556741313 | NARROW BENT HOHMAN RETRACTOR |
| 00885556741306 | DA COBRA RETRACTOR |
| 00885556740705 | CUP ALIGNMENT HANDLE |
| 00885556740699 | CUP IMPACTOR ADAPTER |
| 00885556739280 | R3 SCREW-IN TRIAL LINER 0¿8/60 |
| 00885556738597 | SWIVEL CUP INSERTER |
| 00885556736302 | ALIGNMENT GUIDE |
| 00885556736296 | R3 CUP IMPACTOR |
| 00885556736289 | R3 SCREW-IN TRIAL LINER 0 DEGREE 40/56 |
| 00885556736272 | R3 SCREW-IN TRIAL LINER 20 DEGREE 36/52 |
| 00885556732908 | SUPERPATH RETRACTOR |
| 00885556732892 | U-RETRACTOR |
| 00885556732670 | R3 SCREW-IN TRIAL LINER 20¿6/56 |
| 00885556732663 | R3 SCREW-IN TRIAL LINER 20¿6/54 |
| 00885556732656 | R3 SCREW-IN TRIAL LINER 20¿6/52 |
| 00885556732649 | R3 SCREW-IN TRIAL LINER 20¿2/50 |
| 00885556732632 | R3 SCREW-IN TRIAL LINER 20¿2/48 |
| 00885556732625 | R3 SCREW-IN TRIAL LINER 0¿6/56 |
| 00885556732618 | R3 SCREW-IN TRIAL LINER 0¿6/54 |
| 00885556732601 | R3 SCREW-IN TRIAL LINER 0¿6/52 |
| 00885556732595 | R3 SCREW-IN TRIAL LINER 0¿2/50 |
| 00885556732588 | R3 SCREW-IN TRIAL LINER 0¿2/48 |
| 00885556732564 | R3 CUP IMPACTOR |
| 00885556732557 | MODIFIED R3 INSERTER |
| 00885556732540 | R3 ANTI-ROTATION TIP W/FLAT SZ66/68MM |
| 00885556732533 | R3 ANTI-ROTATION TIP W/FLAT SZ64MM |
| 00885556732526 | R3 ANTI-ROTATION TIP W/FLAT SZ62MM |
| 00885556732519 | R3 ANTI-ROTATION TIP W/FLAT SZ60MM |
| 00885556732502 | R3 ANTI-ROTATION TIP W/FLAT SZ58MM |
| 00885556732496 | R3 ANTI-ROTATION TIP W/FLAT SZ56MM |
| 00885556732472 | R3 ANTI-ROTATION TIP W/FLAT SZ54MM |
| 00885556732465 | R3 ANTI-ROTATION TIP W/FLAT SZ52MM |
| 00885556732458 | R3 ANTI-ROTATION TIP W/FLAT SZ50MM |
| 00885556732441 | R3 ANTI-ROTATION TIP W/FLAT SZ48MM |
| 00885556732434 | R3 ANTI-ROTATION TIP W/FLAT SZ46MM |
| 00885556732144 | CANNULA |
| 00885556732137 | CUP IMPACTOR TIP |
| 00885556732120 | LINER IMPACTOR - 40MM |
| 00885556732113 | LINER IMPACTOR - 36MM |
| 00885556732106 | LINER IMPACTOR - 32MM |
| 00885556732090 | LINER IMPACTOR - 28MM |
| 00885556732083 | REAMER CONNECTOR |
| 00885556732076 | INSERTER TOOL |
| 00885556732069 | LINER IMPACTOR FORCEPS |
| 00885556732052 | IMPACTOR HANDLE |
| 00885556732045 | REAMER HANDLE |
| 00885556732038 | TROCAR |
| 00885556732021 | HANDS FREE RETRACTOR - RIGHT |
| 00885556732014 | HANDS FREE RETRACTOR - LEFT |
| 00885556732007 | LARGE ANTERIOR RETRACTOR |