Vilex Fibula Nail N60-32-105CR

GUDID 00841731119544

Fibula Nail, 105mm, Right Ti

VILEX IN TENNESSEE, INC.

Arthrodesis nail, non-sterile

• Primary Device ID: 00841731119544
• NIH Device Record Key: 6e6cff08-7bf1-4723-9ea3-c39478465413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Fibula Nail
• Version Model Number: N60-32-105CR
• Catalog Number: N60-32-105CR
• Company DUNS: 152008371
• Company Name: VILEX IN TENNESSEE, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731119544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151456

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[00841731119544]

Moist Heat or Steam Sterilization

[00841731119544]

Moist Heat or Steam Sterilization

[00841731119544]

Moist Heat or Steam Sterilization

[00841731119544]

Moist Heat or Steam Sterilization

[00841731119544]

Moist Heat or Steam Sterilization

[00841731119544]

Moist Heat or Steam Sterilization

[00841731119544]

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: 2017-08-11

On-Brand Devices [Vilex Fibula Nail]

• 00841731119599: Fibula Nail, End Cap Ti
• 00841731119582: Fibula Nail, 170mm, Right Ti
• 00841731119575: Fibula Nail, 170mm, Left Ti
• 00841731119568: Fibula Nail, 140mm, Right Ti
• 00841731119551: Fibula Nail, 140mm, Left TI
• 00841731119544: Fibula Nail, 105mm, Right Ti
• 00841731119537: Fibula Nail, 105mm, Left Ti
• 00841731119520: Screw, Fibula Nail 3.5x70mm Ti V. Purple
• 00841731119513: Screw, Fibula Nail 3.5x65mm Ti V. Purple
• 00841731119506: Screw, Fibula Nail 3.5x60mm Ti V. Purple
• 00841731119490: Screw, Fibula Nail 3.5x55mm Ti V. Purple
• 00841731119483: Screw, Fibula Nail 3.5x50mm Ti V. Purple
• 00841731119476: Screw, Fibula Nail 3.5x45mm Ti V. Purple
• 00841731119469: Screw, Fibula Nail 3.5x40mm Ti V. Purple
• 00841731119452: Screw, Fibula Nail 2.7x28mm Ti L. Blue
• 00841731119445: Screw, Fibula Nail 2.7x26mm Ti L. Blue
• 00841731119438: Screw, Fibula Nail 2.7x24mm Ti L. Blue
• 00841731119421: Screw, Fibula Nail 2.7x22mm Ti L. Blue
• 00841731119414: Screw, Fibula Nail 2.7x20mm Ti L. Blue
• 00841731119407: Screw, Fibula Nail 2.7x18mm Ti L. Blue
• 00841731119391: Screw, Fibula Nail 2.7x16mm Ti L. Blue
• 00841731119384: Screw, Fibula Nail 2.7x14mm Ti L. Blue
• 00841731119377: Screw, Fibula Nail 2.7x12mm Ti L. Blue