Futura™ CSI
GUDID 00846832006328
TORNIER, INC.
Partial metatarsophalangeal joint prosthesis| Primary Device ID | 00846832006328 |
| NIH Device Record Key | c44a2f54-1a68-4dc4-9831-75155b8bedcf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Futura™ CSI |
| Version Model Number | CSI-11 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832006328 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032902
FDA Product Code
| HWC | Screw, Fixation, Bone |
| KYI | PROSTHESIS, WRIST, CARPAL TRAPEZIUM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Futura™ CSI]
| 00846832006335 | CSI-12 |
| 00846832006328 | CSI-11 |
| 00846832006311 | CSI-10 |
| 00846832006304 | CSI-09 |
| 00846832006298 | CSI-08 |
| 00846832006281 | CSI-07 |
Trademark Results [Futura]
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