Nitinex Memory Staple

GUDID 00841731106728

Staple, Nitinex 12x17x15mm

VILEX IN TENNESSEE, INC.

Orthopaedic bone staple, non-adjustable, non-sterile

• Primary Device ID: 00841731106728
• NIH Device Record Key: 5556e248-9a2a-4935-8eca-a1e38c148812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nitinex Memory Staple
• Version Model Number: ST-121715
• 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	00841731106728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112837

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[00841731106728]

Moist Heat or Steam Sterilization

[00841731106728]

Moist Heat or Steam Sterilization

[00841731106728]

Moist Heat or Steam Sterilization

[00841731106728]

Moist Heat or Steam Sterilization

[00841731106728]

Moist Heat or Steam Sterilization

[00841731106728]

Moist Heat or Steam Sterilization

[00841731106728]

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: 2016-08-03

On-Brand Devices [Nitinex Memory Staple]

• 00841731120212: Staple, Nitinex 15x20x20mm
• 00841731120045: Staple, Nitinex 12x20x20mm
• 00841731120038: Staple, Nitinex 10x20x20mm
• 00841731119216: Staple, Alpine 10x13x11mm
• 00841731106827: Staple, Nitinex 25x22x22mm
• 00841731106810: Staple, Nitinex 25x16x16mm
• 00841731106803: Staple, Nitinex 20x20x20mm
• 00841731106797: Staple, Nitinex 20x16x16mm
• 00841731106780: Staple, Nitinex 18x17x15mm
• 00841731106773: Staple, Nitinex 18x14x14mm
• 00841731106766: Staple, Nitinex 18x12x12mm
• 00841731106759: Staple, Nitinex 15x15x15mm
• 00841731106742: Staple, Nitinex 15x12x12mm
• 00841731106735: Staple, Nitinex 12x19x16mm
• 00841731106728: Staple, Nitinex 12x17x15mm
• 00841731106711: Staple, Nitinex 12x15x13mm
• 00841731106704: Staple, Nitinex 12x10x10mm
• 00841731106698: Staple, Nitinex 10x17x15mm
• 00841731106681: Staple, Nitinex 10x15x13mm
• 00841731106674: Staple, Nitinex 10x10x10mm
• 00841731106667: Staple, Nitinex 08x10x10mm
• 00841731106650: Staple, Nitinex 08x08x08mm