SALVATION
GUDID 00840420160850
WRIGHT MEDICAL TECHNOLOGY, INC.
External orthopaedic fixation system, single-use, sterile| Primary Device ID | 00840420160850 |
| NIH Device Record Key | 397e4178-0386-4925-9a9c-06034906804b |
| Commercial Distribution Discontinuation | 2015-11-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SALVATION |
| Version Model Number | SEF540HA |
| Company DUNS | 807201207 |
| Company Name | WRIGHT MEDICAL TECHNOLOGY, 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 | 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 | +1(800)238-7117 |
| customerservice@wmt.com |
Device Dimensions
| Length | 180 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420160850 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150004
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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-01 |
On-Brand Devices [SALVATION]
Trademark Results [SALVATION]
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