BIOSURE 72201783
GUDID 03596010611796
BIOSURE HA 9MM X 35MM
Smith & Nephew, Inc.
Orthopaedic bone screw, bioabsorbable| Primary Device ID | 03596010611796 |
| NIH Device Record Key | e74c3511-87be-44c1-86af-000be09215c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOSURE |
| Version Model Number | 72201783 |
| Catalog Number | 72201783 |
| 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 | 03596010611796 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080358
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 | 2015-08-29 |
On-Brand Devices [BIOSURE]
| 00885556686225 | RFB INSTRUMENT TRAY BIOSR SYNC |
| 00885556572788 | REFURBISHED BIOSUTURE TAP 10MM |
| 00885556572771 | REFURBISHED BIOSURETAP9MM |
| 00885556572764 | REFURBISHED BIOSUTURE TAP 8MM |
| 00885556572757 | REFURBISHED BIOSURE TAP 7MM |
| 00885556572740 | REFURBISHED BIOSURE TAP 6MM |
| 00885556572733 | REFURBISHEDBIOSURE RACHET DRIVER |
| 00885556572726 | REFURBISHED BIOSUTURE DRIVER |
| 00885556572047 | REFURBISHEDBIOSURE EASY TAP10MM |
| 00885556572030 | REFURBISHEDBIOSURE EASY TAP9MM |
| 00885556572023 | REFURBISHEDBIOSURE EASY TAP8MM |
| 00885556572016 | REFURBISHEDBIOSURE EASY TAP7MM |
| 00885556572009 | REFURBISHED BIOSUTURE EASY TAP 6MM |
| 00885554037463 | BIOSURE DRIVER 5MM |
| 00885554028201 | DRIVER BIOSURE NON-CANLTD W/GUIDED TIP |
| 00885554027228 | FLEXIBLE TAP BIOSURE 10MM |
| 00885554027211 | FLEXIBLE TAP BIOSURE 9MM |
| 00885554027204 | FLEXIBLE TAP BIOSURE 8MM |
| 00885554027198 | FLEXIBLE TAP BIOSURE 7MM |
| 00885554027181 | FLEXIBLE TAP BIOSURE 6MM |
| 00885554027174 | FLEXIBLE DRIVER BIOSURE |
| 00885554016741 | MTO DRVR EXTENDED BIOSURE RATCHETED |
| 00885554016550 | MTO TAP BIOSURE EASY 8MM |
| 00885554015416 | TRAY BIOSURE EASY TAPS |
| 00885554015010 | TRAY BIOSURE TAPS |
| 03596010649010 | INSERTER BIOSURE SYNC |
| 08855540272040 | FLEXIBLE TAP BIOSURE 8MM |
| 08855540271982 | FLEXIBLE TAP BIOSURE 7MM |
| 08855540271814 | FLEXIBLE TAP BIOSURE 6MM |
| 03596010652546 | INSTRUMENT TRAY BIOSURE SYNC |
| 03596010649065 | DILATOR 11-12MM BIOSURE SYNC |
| 03596010649058 | DILATOR 9-10MM BIOSURE SYNC |
| 03596010649041 | DILATOR 7-8MM BIOSURE SYNC |
| 03596010649034 | DILATOR 5-6MM BIOSURE SYNC |
| 03596010649027 | TENSIONER BIOSURE SYNC |
| 03596010649003 | BIOSURE SYNC 11-12MM TIBIAL FIXATION |
| 03596010648990 | BIOSURE SYNC 9-10MM TIBIAL FIXATION |
| 03596010648983 | BIOSURE SYNC 7-8MM TIBIAL FIXATION |
| 03596010648976 | BIOSURE SYNC 5-6MM TIBIAL FIXATION |
| 03596010615497 | BIOSURE EASY TAP 10MM |
| 03596010615480 | BIOSURE EASY TAP 9MM |
| 03596010615473 | BIOSURE EASY TAP 8MM |
| 03596010615466 | BIOSURE EASY TAP 7MM |
| 03596010615459 | BIOSURE EASY TAP 6MM |
| 03596010615442 | BIOSURE RATCHET DRIVER |
| 03596010615398 | BIOSURE DRIVER |
| 03596010615381 | BIOSURE TAP 10MM |
| 03596010615374 | BIOSURE TAP 9MM |
| 03596010615367 | BIOSURE TAP 8MM |
| 03596010615350 | BIOSURE TAP 7MM |
Trademark Results [BIOSURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSURE 87636308 5443366 Live/Registered |
Smith & Nephew, Inc. 2017-10-06 |
 BIOSURE 79221141 5567730 Live/Registered |
Biosure (UK) Ltd 2016-03-04 |
 BIOSURE 78258034 not registered Dead/Abandoned |
General Electric Company 2003-06-04 |
 BIOSURE 78241123 2817555 Live/Registered |
Biosure, Inc. 2003-04-23 |
 BIOSURE 77800327 4051245 Dead/Cancelled |
CORPORATIVE BRANDINGS AND INVESTMENTS, S.A. DE C.V. 2009-08-08 |
 BIOSURE 77694180 3730800 Live/Registered |
Challenger Products, LLC 2009-03-18 |
 BIOSURE 77443660 3673947 Dead/Cancelled |
Smith & Nephew, Inc. 2008-04-09 |
 BIOSURE 75447669 2249388 Dead/Cancelled |
ACC Hall International, Inc. 1998-03-10 |
 BIOSURE 75427732 2259048 Live/Registered |
Biosure, Inc. 1998-02-02 |
 BIOSURE 74608424 1945465 Live/Registered |
BIOSURE, INC. 1994-12-08 |
 BIOSURE 74537967 not registered Dead/Abandoned |
NOVO NORDISK A/S 1994-06-15 |
 BIOSURE 73651004 1477250 Dead/Cancelled |
E. I. DU PONT DE NEMOURS AND COMPANY 1987-03-18 |
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