PHALINX
GUDID 00840420166036
WRIGHT MEDICAL TECHNOLOGY, INC.
Interphalangeal joint arthrodesis implant| Primary Device ID | 00840420166036 |
| NIH Device Record Key | dcc1c29b-dc4a-459e-bdf3-4c66290219f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHALINX |
| Version Model Number | 45301002 |
| 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 | 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)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com | |
| Phone | +1(800)238-7117 |
| customerservice@wmt.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840420166036 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142585
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
[00840420166036]
Moist Heat or Steam Sterilization
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 [PHALINX]
Trademark Results [PHALINX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHALINX 85852994 4486281 Live/Registered |
WRIGHT MEDICAL TECHNOLOGY, INC. 2013-02-18 |
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