Scwire 00-1070-005
GUDID 00841132123966
2.5 Compression Nut
ORTHOPEDIATRICS CORP.
Femur nail, sterile| Primary Device ID | 00841132123966 |
| NIH Device Record Key | ecbaf0ed-117c-428f-a069-62d3cf83f1cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scwire |
| Version Model Number | 00-1070-005 |
| Catalog Number | 00-1070-005 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841132123966 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031050
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-30 |
On-Brand Devices [Scwire]
| 00841132123973 | 2.5 Flat Washer |
| 00841132123966 | 2.5 Compression Nut |
| 00841132123959 | 2.5mm Compression Nut |
Trademark Results [Scwire]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCWIRE 78360277 2988230 Live/Registered |
ORTHOPEDIATRICS CORPORATION 2004-01-30 |
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