Viper® Distal Volar Radius Plating System 28006401
GUDID M248280064011
The Viper distal volar radius plate consists of four holes with left to right configuration.
Ascension Orthopedics, Inc.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | M248280064011 |
| NIH Device Record Key | e619549f-98c4-46be-b27c-f7dead08e25c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Viper® Distal Volar Radius Plating System |
| Version Model Number | 28006401 |
| Catalog Number | 28006401 |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, 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 | 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
Device Dimensions
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid contact with any object or material which may damage the surface finish. Store in indicated location inside instrument case. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780065098 [Primary] |
| HIBCC | M248280064011 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041461
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
[M248280064011]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [Viper® Distal Volar Radius Plating System]
| M2486000111 | 1.1MM K-WIRE |
| M2486050271 | VIPER/VALT 2.7MM DRILL BIT |
| M2486050201 | VIPER/VALT 2.0MM DRILL BIT |
| M2486050021 | VALT KEY LOCK DRIVER |
| M2486050011 | VALT PLACEMENT DRIVER |
| M248281350161 | The Viper cortical titanium screw, which is placed proximally. |
| M248281350121 | The Viper cortical titanium screw, which is placed proximally. |
| M248280066011 | The Viper distal volar radius plate consists of six holes with left to right configuration. |
| M248280064011 | The Viper distal volar radius plate consists of four holes with left to right configuration. |
| M248271427301 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427201 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427181 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427161 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M248271427121 | The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally. |
| M268VIPERSET0 | The VIPERSET consists of a distal volar radius plate with the option of either a 4-hole or 6-hol |
Trademark Results [Viper]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIPER 98774058 not registered Live/Pending |
Proven Winners North America LLC 2024-09-27 |
 VIPER 98576205 not registered Live/Pending |
Total Finishing Solutions, LLC. 2024-05-30 |
 VIPER 98543368 not registered Live/Pending |
Greg Lucero 2024-05-10 |
 VIPER 98512687 not registered Live/Pending |
S&B Technical Products, Inc. 2024-04-22 |
 VIPER 98484950 not registered Live/Pending |
VM Products, Inc. 2024-04-04 |
 VIPER 98484922 not registered Live/Pending |
VM Products, Inc. 2024-04-04 |
 VIPER 98484879 not registered Live/Pending |
Cala Industries, Inc. 2024-04-04 |
 VIPER 98468050 not registered Live/Pending |
PATRIOT MEMORY, INC. 2024-03-26 |
 VIPER 98385826 not registered Live/Pending |
Gaatu Inc. 2024-02-01 |
 VIPER 98310533 not registered Live/Pending |
RFA Brands, LLC d/b/a My Charge 2023-12-12 |
 VIPER 98299117 not registered Live/Pending |
Delta T, LLC 2023-12-05 |
 VIPER 98192919 not registered Live/Pending |
Gaatu Inc. 2023-09-22 |
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