DigiFuse® Cannulated Intramedullary Fusion System DF1500
GUDID M269DF15001
Integra® DigiFuse® The ratchet handle is used in conjunction with the Integra DigiFuse system.
Ascension Orthopedics, Inc.
Surgical instrument handle, non-torque-limiting| Primary Device ID | M269DF15001 |
| NIH Device Record Key | be732afe-42e3-4e66-b7a1-238df4328953 |
| Commercial Distribution Discontinuation | 2026-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DigiFuse® Cannulated Intramedullary Fusion System |
| Version Model Number | DF1500 |
| Catalog Number | DF1500 |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780244424 [Primary] |
| HIBCC | M269DF15001 [Secondary] |
FDA Product Code
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
[M269DF15001]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-02-22 |
| Device Publish Date | 2017-09-05 |
On-Brand Devices [DigiFuse® Cannulated Intramedullary Fusion System]
| M269DF26801 | Integra® DigiFuse® The forceps are used for screw pickup in the Integra DigiFuse system. |
| M269DT4500L1 | Integra® DigiFuse® The DigiFuse Lid is the top part of the sterilization tray which locks onto |
| M269DT45001 | Integra® DigiFuse® The DigiFuse Instrument Sterilization Tray is designed to contain, secure, |
| M269DT3500LID1 | Integra® DigiFuse® The DigiFuse Lid is the top part of the tray which locks onto the base and |
| M269DT35001 | Integra® DigiFuse® The DigiFuse Instrument Sterilization Tray is designed to contain, secure, |
| M269DF26101 | Integra® DigiFuse® The DigiFuse driver shaft is used to create holes when inserted into a driv |
| M269DF26001 | Integra® DigiFuse® The DigiFuse driver shaft is used to create holes when inserted into a driv |
| M269DF15001 | Integra® DigiFuse® The ratchet handle is used in conjunction with the Integra DigiFuse system. |
| M269DW25901 | Integra® DigiFuse® The smooth guide wire is used as a guide for placement or insertion of a de |
Trademark Results [DigiFuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGIFUSE 86841597 5079596 Live/Registered |
Landscape Structures Inc. 2015-12-07 |
 DIGIFUSE 85318180 4172802 Live/Registered |
ASCENSION ORTHOPEDICS, INC. 2011-05-11 |
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