GALAXY FIXATION 99-939010
GUDID 18053340349864
SEMI CIRCULAR ROD D 9 MM SMALL STERILE
ORTHOFIX SRL
External orthopaedic fixation system, single-use, sterile| Primary Device ID | 18053340349864 |
| NIH Device Record Key | c56055b0-5792-4817-870b-c4ed9d7bbae9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GALAXY FIXATION |
| Version Model Number | 1 |
| Catalog Number | 99-939010 |
| Company DUNS | 438793622 |
| Company Name | ORTHOFIX SRL |
| 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 | true |
| 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 | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it |
Device Dimensions
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18053340349864 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113770
FDA Product Code
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-22 |
| Device Publish Date | 2021-06-14 |
On-Brand Devices [GALAXY FIXATION]
| 18053340349871 | SEMI CIRCULAR ROD D 9 MM MEDIUM STERILE |
| 18053340349864 | SEMI CIRCULAR ROD D 9 MM SMALL STERILE |
| 18053340349857 | 6 MM L ROD STERILE |
| 18053340349888 | SEMI CIRCULAR ROD D 9 MM LARGE STERILE |
Trademark Results [GALAXY FIXATION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAXY FIXATION 79344267 not registered Live/Pending |
ORTHOFIX S.R.L. 2022-04-05 |
 GALAXY FIXATION 79104979 4766276 Live/Registered |
ORTHOFIX S.r.l. 2011-10-07 |
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