| Primary Device ID | 00885556861523 |
| NIH Device Record Key | 8f83e4f3-9c54-4917-b71b-d1b70e5aa6ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Instruments |
| Version Model Number | NR135004-J-004 |
| Catalog Number | NR135004-J-004 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556861523 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
[00885556861523]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-07 |
| Device Publish Date | 2022-12-21 |
| 00885556864197 | RSS DRILL DEPTH GAUGE |
| 00885556862247 | 1/8 HEX DRIVER |
| 00885556862186 | SLAP HAMMER |
| 00885556861691 | GLENOID RETRACTOR S |
| 00885556861684 | GLENOID RETRACTOR L |
| 00885556861677 | HOHMAN RETRACTOR |
| 00885556861660 | DARRACH RETRACTOR 11S |
| 00885556861653 | DARRACH RETRACTOR 11L |
| 00885556856635 | CASE LID |
| 00885556856499 | PIP ALIGNMENT AWL |
| 00885556856475 | ALIGNMENT GUIDE. E/M |
| 00885556854747 | GENERIC CASE LID HALF SIZE |
| 00885556834985 | FORCEPS. SCREW HOLDING |
| 00885556830970 | KOLBEL RETRACTOR FRAME |
| 00885556830963 | FUKUDA RETRACTOR SMALL |
| 00885556830925 | HOHMAN RETRACTOR |
| 00885556830918 | DELTOID RETRACTOR |
| 00885556830833 | SIZING TEMPLATE. PHS SZ. 50 |
| 00885556830826 | SIZING TEMPLATE. PHS SZ. 40 |
| 00885556830819 | SIZING TEMPLATE. PHS SZ. 30 |
| 00885556830802 | SIZING TEMPLATE. PHS SZ. 20 |
| 00885556830796 | SIZING TEMPLATE. PHS SZ. 10 |
| 00885556829967 | 2.4MM PROVISIONAL FIXATION PIN |
| 00885556829950 | DRILL GUIDE DEPTH GAUGE |
| 00885556829943 | PLATE DEPTH GAUGE |
| 00885556829936 | 2.4MM LOCKING DRILL GUIDE |
| 00885556829752 | 3.5MM DIA DRILL WITH AO CONNECTION |
| 00885556829745 | 2.4MM DIA X 80MM DEPTH DRILL WITH AO CONNECTION |
| 00885556829738 | 1.9MM DIA X 50MM DEPTH DRILL WITH AO CONNECTION |
| 00885556829721 | 3.5MM DRILL GUIDE |
| 00885556829714 | 3.5MM SCREW GUIDE |
| 00885556829707 | 2.4MM DRILL GUIDE |
| 00885556829646 | PERIOSTEAL ELEVATOR |
| 00885556829639 | TORX 8 DRIVE SHAFT |
| 00885556829622 | TORX 15 DRIVE SHAFT |
| 00885556829615 | BONE REDUCTION FCPS STR 9IN |
| 00885556829608 | BONE REDUCTION FORCEPS CURVED 8IN |
| 00885556829592 | AO TO TRINKLE ADAPTER |
| 00885556859988 | RETRACTOR BASE |
| 00885556863664 | 2.8MM DRILL BIT FOR 5.5 SCREWS |
| 00885556863657 | 2.5 DRILL BIT FOR 4.5 SCREWS |
| 00885556861721 | KOLBEL RETRACTOR BLADE X-LARGE |
| 00885556861714 | KOLBEL RETRACTOR BLADE SMALL |
| 00885556861707 | KOLBEL RETRACTOR BLADE LARGE |
| 00885556861523 | T-HANDLE. FIXED. NO CANNULATION. BLUE |
| 00885556860274 | TORQUE LIMITER |
| 00885556859193 | PIN PULLER |
| 00885556857328 | IMPLANT IMPACTOR |
| 00885556856680 | EXTRACTOR |
| 00885556856628 | CUP AND CONE REAMER LID (CADDY) |