Impactor 202-1001
GUDID 00810097801042
Impactor
SMV SCIENTIFIC LLC
Sacroiliac joint transarticular fixation/arthrodesis implantation kit| Primary Device ID | 00810097801042 |
| NIH Device Record Key | 9ec06f9f-6a79-42bc-9582-996c6320175f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Impactor |
| Version Model Number | 202-1001 |
| Catalog Number | 202-1001 |
| Company DUNS | 089645059 |
| Company Name | SMV SCIENTIFIC LLC |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com | |
| Phone | 1-800-969-0639 |
| quality@osteocentric.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810097801042 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230226
FDA Product Code
| HWA | Impactor |
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
[00810097801042]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-24 |
| Device Publish Date | 2022-08-16 |
On-Brand Devices [Impactor ]
| 00816950029462 | Impactor |
| 00810097801042 | Impactor |
Trademark Results [Impactor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMPACTOR 86898583 5044668 Live/Registered |
Smarter Trash, Inc. 2016-02-05 |
 IMPACTOR 79089957 4192391 Dead/Cancelled |
SumiRiko SD France S.A.S. 2010-06-16 |
 IMPACTOR 78533251 3175111 Dead/Cancelled |
Latimark, Inc. 2004-12-15 |
 IMPACTOR 77175942 not registered Dead/Abandoned |
Carrion, Richard 2007-05-08 |
 IMPACTOR 76419811 2688675 Live/Registered |
THE CHARLES MACHINE WORKS, INC. 2002-06-12 |
 IMPACTOR 76414929 2790434 Dead/Cancelled |
Earth Tool Company, L.L.C. 2002-06-05 |
 IMPACTOR 75239921 2147476 Dead/Cancelled |
Omega Environmental Products, Inc. 1997-02-11 |
 IMPACTOR 74507980 not registered Dead/Abandoned |
SUFFOLK MACHINE CORPORATION 1994-04-01 |
 IMPACTOR 74198047 1793690 Dead/Cancelled |
CARSONITE INTERNATIONAL CORP. 1991-08-26 |
 IMPACTOR 73749608 1531885 Dead/Cancelled |
GIANT BICYCLE, INC. 1988-09-01 |
 IMPACTOR 71519383 0505155 Dead/Expired |
EDWARD VALVES, INC. 1947-07-24 |
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