SMARTSTITCH OM-8000
GUDID 00817470001679
SMARTSTITCH SUTURE DEVICE HANDLE
Smith & Nephew, Inc.
Suturing unit, reusable| Primary Device ID | 00817470001679 |
| NIH Device Record Key | 3176bb1b-954e-45e6-b49e-d129d7314b44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTSTITCH |
| Version Model Number | OM-8000 |
| Catalog Number | OM-8000 |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817470001679 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123268
FDA Product Code
| NBH | ACCESSORIES,ARTHROSCOPIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
[00817470001679]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-11-13 |
Devices Manufactured by Smith & Nephew, Inc.
| 00885556900260 - TRIGEN MAX | 2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI |
| 00885556898741 - INTERTAN MAX | 2025-12-24 INTERTAN MAX COMPRESSION SCREW 35MM |
| 00885556721292 - N/A | 2025-12-23 GENERIC FULL TRAY LID |
| 00885556746004 - SMART TSF | 2025-12-23 SMART TSF DYNAMIZATION KIT (6+6) |
| 00885556917800 - EVOS | 2025-12-22 EVOS 3.5MM X 56MM CORTEX SCREW SELF-TAPPING |
| 00885556917817 - EVOS | 2025-12-22 EVOS 3.5MM X 58MM CORTEX SCREW SELF-TAPPING |
| 00885556917824 - EVOS | 2025-12-22 EVOS 3.5MM X 52MM LOCKING SCREW SELF-TAPPING |
| 00885556917831 - EVOS | 2025-12-22 EVOS 3.5MM X 54MM LOCKING SCREW SELF-TAPPING |
Trademark Results [SMARTSTITCH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTSTITCH 97911444 not registered Live/Pending |
NINGBO XINBOSI DIANZISHANGWU CO., LTD. 2023-04-27 |
 SMARTSTITCH 78681007 3129291 Dead/Cancelled |
ArthroCare Corporation 2005-07-28 |
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