Dynex

GUDID 00841731124319

Washer, Rectangular 1mm

VILEX LLC

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00841731124319
• NIH Device Record Key: f1f0ea0a-c4c7-4830-aee6-dff0b7d09c17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynex
• Version Model Number: DF-R635-01-R
• Company DUNS: 117502293
• Company Name: VILEX LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731124319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202054

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

[00841731124319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-28
• Device Publish Date: 2021-09-20

On-Brand Devices [Dynex]

• 00841731124616: Drill 4.5x250mm Solid
• 00841731126283: Wire Sharp Bayonet 1.8x400mm
• 00841731126276: Wire Sharp Bayonet 1.8x400mm HA Sterile
• 00841731126269: Wire Sharp Bayonet Olive 1.8x400mm HA Sterile
• 00841731126252: Wire Sharp Bayonet Olive 1.8x400mm
• 00841731124609: Drill 3.2x250mm Solid
• 00841731124586: Drill 4.5x200mm Cannulated
• 00841731124555: Drill 3.2x200mm Cannulated
• 00841731124548: Drill 4.5x185mm Solid
• 00841731124531: Drill 3.2x185mm Solid
• 00841731124524: Drill 2.0x185mm Solid
• 00841731123923: Kwire, Sharp Bayonet, 250mmx1.8mm
• 00841731126412: Half Pin, 6.0x200x60 Button, HA, Sterile Pkgd.
• 00841731126405: Half Pin, 6.0x200x55 Button HA, Sterile Pkgd
• 00841731126399: Half Pin, 6.0x200x50 Button, HA, Sterile Pkgd.
• 00841731126382: Half Pin, 6.0x200x45 Button HA, Sterile Pkdg
• 00841731126375: Half Pin, 6.0x200x40 Button, HA, Sterile Kg.
• 00841731126368: Half Pin, 6.0x200x35 Button HA, Sterile Pkgd
• 00841731126351: Half Pin, 6.0x200x30 Button, HA, Sterile Pkgd.
• 00841731126344: Half Pin, 6.0x200x25 Button HA, Sterile Pkgd
• 00841731126337: Half Pin, 6.0x200x20 Button, HA, Sterile Pkgd.
• 00841731126320: Half Pin, 6.0x200x15 Button HA, Sterile Pkgd
• 00841731126313: Half Pin, 6.0x200x10 Button, HA Sterile Pkgd
• 00841731126191: Half Pin, 4.5x200x60 Button, HA, Sterile Pkgd.
• 00841731125958: Shoe, (Pair)
• 00841731125897: Spring, Shoe Suspension (4/pk)
• 00841731125866: Nut, Thrd coupling 60mm
• 00841731125842: Nut, Thrd coupling 40mm
• 00841731125804: Nut, Thrd Coupling 18mm
• 00841731125798: Bolt, Half Pin Washerless
• 00841731125781: Bolt, Half Pin w/Washer
• 00841731125774: Washer, Slotted
• 00841731125712: Nut, Counting Short
• 00841731125705: Nut, Counting Medium
• 00841731125699: Nut, Counting Long
• 00841731125675: Nut, 10mm x 6mm SS (Thick)
• 00841731125668: Nut, 10mm
• 00841731125651: Bolt, Wire Long
• 00841731125644: Bolt, Wire
• 00841731125620: Bolt, 30mm
• 00841731125606: Bolt, 20mm
• 00841731125590: Bolt, 16mm
• 00841731125576: Bolt, 12mm
• 00841731125545: Bolt, 8mm
• 00841731125439: Hinge, 90 degree
• 00841731125422: Hinge, Universal
• 00841731123824: Half Pin Removal Tool (LB)
• 00841731126184: Half Pin, 4.5x200x55 Button HA, Sterile Pkgd
• 00841731126177: Half Pin, 4.5x200x50 Button, HA, Sterile Pkgd.
• 00841731126160: Half Pin, 4.5x200x45 Button HA, Sterile Pkgd