SPEEDSCREW OM-9650
GUDID 00817470002638
SPEEDSCREW OBTURATOR
Smith & Nephew, Inc.
Surgical drill guide obturator| Primary Device ID | 00817470002638 |
| NIH Device Record Key | 22a73914-e1fb-4acf-b672-1a0cecc85c6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEEDSCREW |
| Version Model Number | OM-9650 |
| Catalog Number | OM-9650 |
| Company DUNS | 109903521 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817470002638 [Primary] |
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
[00817470002638]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2015-09-21 |
On-Brand Devices [SPEEDSCREW]
| 00817470006414 | SPEEDSCREW PLUS W/MC MGW COBRAID |
| 00817470006407 | SPEEDSCREW W/MC MGW WHITE |
| 00817470006391 | SPEEDSCREW PLUS W/PP MGW COBRAID |
| 00817470006384 | SPEEDSCREW PLUS W/PP MGW WHITE |
| 00817470005233 | 6.5MM SPEEDSCREW PLUS PP MAGNMWIRE COBRD |
| 00817470005226 | 6.5MM SPEEDSCREW PLUS PP MAGNMWIRE WHIT |
| 00817470005219 | 6.5MM SPEEDSCREW PLUS MC MW BLK COBRAID |
| 00817470005202 | 6.5MM SPEEDSCREW PLUS MC MAGNMWIRE COBRD |
| 00817470005196 | OPUS SPEEDSCREW IMPLANT |
| 00817470005172 | 5.5 SPEEDSCREW PLUS (BLACK COBRAID MW) |
| 00817470004625 | 6.5MM SPEEDSCREW PLUS MC MAGNMWIRE WHITE |
| 00817470004076 | SPEEDSCREW 6.5MM |
| 00817470002904 | SPEEDSCREW INSERTION GUIDE |
| 00817470002638 | SPEEDSCREW OBTURATOR |
| 00817470001259 | SPEEDSCREW 6.5MM PLUS PP MW BLACK COB |
| 00817470001242 | SPEEDSCREW 5.5MM PLUS W/PP MW BLACK COB |
Trademark Results [SPEEDSCREW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEEDSCREW 77573558 3659267 Live/Registered |
ArthroCare Corporation 2008-09-18 |
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