BIORCI 7207561
GUDID 03596010426239
SCR BIORCI 8X30MM STRL BX 1
Smith & Nephew, Inc.
Orthopaedic bone screw, bioabsorbable| Primary Device ID | 03596010426239 |
| NIH Device Record Key | 9578c43c-7d49-49dc-81b6-e44c90b7f929 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIORCI |
| Version Model Number | 7207561 |
| Catalog Number | 7207561 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)821-5700 |
| 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 | |
| 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 | 03596010426239 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K992396
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2015-08-30 |
On-Brand Devices [BIORCI]
| 00885556608937 | MTO BIORCI SCRW 10MMX35MM YLW/ |
| 00885556608920 | MTO BIORCI SCRW 10MMX30MM YLW/ |
| 00885556608913 | MTO BIORCI SCRW 9MMX35MM YLW/ |
| 00885556608906 | MTO BIORCI SCRW 9MMX30MM YLW/ |
| 00885556608890 | MTO BIORCI SCRW 9MMX25MM YLW/ |
| 00885556608883 | MTO BIORCI SCRW 8MMX35MM YLW/ |
| 00885556608876 | MTO BIORCI SCRW 8MMX30MM YLW/ |
| 00885556608869 | MTO BIORCI SCRW 8MMX25MM YLW/ |
| 00885556608852 | MTO BIORCI SCRW 7MM8MM HDX30 |
| 00885556608845 | MTO BIORCI SCRW 7MM8MM HDX25 |
| 00885556608838 | MTO BIORCI SCRW 7MM7MM HDX25 |
| 00885556603413 | MTO BIORCI DRIVER W/GRAD MARKS TO 60MM |
| 00885556602225 | SOD DRVR BIORCI NON-CANN W/HDSN ADPTR |
| 00885556601471 | SOD TAP BIORCI 10MM W/THINNER |
| 00885556601464 | SOD TAP BIORCI 9MM W/THINNER |
| 00885556601457 | SOD TAP BIORCI 8MM W/THINNER |
| 00885556601440 | SOD TAP BIORCI 7MM W/THINNER |
| 00885556570012 | REFURB STARTER THREADED SCREW 8MM |
| 00885556569771 | REFURBTAPBIORCI10MM |
| 00885556569764 | REFURBTAPBIORCI9MM |
| 00885556569757 | REFURB TAP BIORCI 8MM |
| 00885556569740 | REFURB BIORCI 7MM |
| 00885556569559 | MTO DRIVER BIORCI W/HUDSON ADAPTOR |
| 00885554010510 | MTO TAP BIORCI 10MM W/HUDSON ADAPTOR |
| 00885554010152 | MTO TAP BIORCI 9MM W/HUDSON ADAPTOR |
| 00885554009835 | MTO TAP BIORCI 8MM W/HUDSON ADAPTOR |
| 00885554009569 | MTO TAP BIORCI 7MM W/HUDSON ADAPTOR |
| 00885554007053 | MTO DRVR BIORCI W/HDSN ADPTR EX 3 IN |
| 00885554001525 | MTO DRIVER BIORCI SCR HUDSON ADAP W/SET |
| 03596010588975 | MTO TAP 7MM BIORCI REVERSE THREAD |
| 03596010525116 | MTO BIORCI FLEXIBLE SCREW DRIVER |
| 03596010485618 | BIORCI SCRW 12MM X 35 STRL |
| 03596010485601 | BIORCI SCRW 11MM X 35MM STRL |
| 03596010485595 | BIORCI SCREW 11MMX30MM STRL BX 1 |
| 03596010485588 | BIORCI SCRW 10MM X 25MM RVRS |
| 03596010485564 | BIORCI SCRW 9MM X 25MM REV |
| 03596010485557 | BIORCI SCRW 9MM X 20MM STRL |
| 03596010485540 | BIORCI SCRW 8MM X 20MM STRL |
| 03596010473189 | MTO DRIVER BIORCI W/HUDSON ADAPTOR |
| 03596010473172 | STARTER THREADED SCREW 8MM |
| 03596010473165 | STARTER THREADED SCREW 7MM |
| 03596010460189 | SCR BIORCI-HA 11X30 STERILE |
| 03596010460110 | SCR BIORCI-HA 10X25 R THR STER |
| 03596010460103 | SCR BIORCI-HA 9X25 R THR STERILE |
| 03596010460097 | SCR BIORCI-HA 8X25 R THD STERILE |
| 03596010460073 | SCR BIORCI-HA 12X35 STERILE |
| 03596010460066 | SCR BIORCI-HA 11X35 STERILE |
| 03596010460059 | SCR BIORCI-HA 10X35 STERILE |
| 03596010460042 | SCR BIORCI-HA 10X30 STERILE |
| 03596010460035 | SCR BIORCI-HA 10X25 STERILE |
Trademark Results [BIORCI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIORCI 75838189 2452137 Live/Registered |
Smith & Nephew, Inc. 1999-11-02 |
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