Orthex Half Pin

GUDID 00841731109538

Half Pin, Orthex 6.0x200x55 Button HA, Sterile Pkgd

VILEX IN TENNESSEE, INC.

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 00841731109538
• NIH Device Record Key: 239a8efe-7397-4aa9-b4c1-8fa49d145b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Half Pin
• Version Model Number: HP60-200-55B
• 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: true
• 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	00841731109538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132820

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

On-Brand Devices [Orthex Half Pin]

• 00841731115102: Half Pin, Orthex 6.0x200x10 Button HA, Sterile Pkgd
• 00841731109750: Half Pin, SB, Orthex 5.0x150x45 Button, HA, Sterile Pkgd.
• 00841731109743: Half Pin, SB, Orthex 5.0x150x40 Button, HA, Sterile Pkgd.
• 00841731109736: Half Pin, SB, Orthex 5.0x150x35 Button, HA, Sterile Pkgd.
• 00841731109729: Half Pin, SB, Orthex 5.0x150x30 Button, HA, Sterile Pkgd.
• 00841731109712: Half Pin, SB, Orthex 5.0x150x25 Button, HA, Sterile Pkgd.
• 00841731109705: Half Pin, SB, Orthex 5.0x150x20 Button, HA, Sterile Pkgd.
• 00841731109699: Half Pin, SB, Orthex5.0x150x15 Button, HA, Sterile Pkgd.
• 00841731109682: Half Pin, SB, Orthex 4.0x150x40 Button, HA, Sterile Pkgd.
• 00841731109675: Half Pin, SB, Orthex 4.0x150x35 Button, HA, Sterile Pkgd.
• 00841731109668: Half Pin, SB, Orthex 4.0x150x30 Button, HA, Sterile Pkgd.
• 00841731109651: Half Pin, SB, Orthex 4.0x150x25 Button, HA, Sterile Pkgd.
• 00841731109644: Half Pin, SB, Orthex 4.0x150x20 Button, HA, Sterile Pkgd.
• 00841731109637: Half Pin, SB, Orthex 4.0x150x15 Button, HA, Sterile Pkgd.
• 00841731109620: Half Pin, SB, Orthex 4.0x150x10 Button, HA, Sterile Pkgd.
• 00841731109613: Half Pin, SB, Orthex 3.0x150x40 Button, HA, Sterile Pkgd.
• 00841731109606: Half Pin, SB, Orthex 3.0x150x35 Button, HA, Sterile Pkgd.
• 00841731109590: Half Pin, SB, Orthex 3.0x150x30 Button, HA, Sterile Pkgd.
• 00841731109583: Half Pin, SB, Orthex 3.0x150x25 Button, HA, Sterile Pkgd.
• 00841731109576: Half Pin, SB, Orthex 3.0x150x20 Button, HA, Sterile Pkgd.
• 00841731109569: Half Pin, SB, Orthex 3.0x150x15 Button, HA, Sterile Pkgd.
• 00841731109552: Half Pin, SB, Orthex 3.0x150x10 Button, HA, Sterile Pkgd
• 00841731109545: Half Pin, Orthex 6.0x200x60 Button, HA, Sterile Pkgd.
• 00841731109538: Half Pin, Orthex 6.0x200x55 Button HA, Sterile Pkgd
• 00841731109521: Half Pin, Orthex 6.0x200x50 Button, HA, Sterile Pkgd.
• 00841731109514: Half Pin, Orthex 6.0x200x45 Button HA, Sterile Pkgd
• 00841731109507: Half Pin, Orthex 6.0x200x40 Button, HA, Sterile Pkgd.
• 00841731109491: Half Pin, Orthex 6.0x200x35 Button HA, Sterile Pkgd
• 00841731109484: Half Pin, Orthex 6.0x200x30 Button, HA, Sterile Pkgd.
• 00841731109477: Half Pin, Orthex 6.0x200x25 Button HA, Sterile Pkgd
• 00841731109460: Half Pin, Orthex 6.0x200x20 Button, HA, Sterile Pkgd.
• 00841731109453: Half Pin, Orthex 6.0x200x15 Button HA, Sterile Pkgd
• 00841731109446: Half Pin, Orthex 4.5x200x60 Button, HA, Sterile Pkgd.
• 00841731109439: Half Pin, Orthex 4.5x200x55 Button HA, Sterile Pkgd
• 00841731109422: Half Pin, Orthex 4.5x200x50 Button, HA, Sterile Pkgd.
• 00841731109415: Half Pin, Orthex 4.5x200x45 Button HA, Sterile Pkgd
• 00841731109408: Half Pin, Orthex 4.5x200x40 Button, HA, Sterile Pkgd.
• 00841731109392: Half Pin, Orthex 4.5x200x35 Button HA, Sterile Pkgd
• 00841731109385: Half Pin, Orthex 4.5x200x30 Button, HA, Sterile Pkgd.
• 00841731109378: Half Pin, Orthex 4.5x200x25 Button HA, Sterile Pkgd
• 00841731109361: Half Pin, Orthex 4.5x200x20 Button, HA, Sterile Pkgd.
• 00841731109354: Half PIn, Orthex 4.5x200x15 Button HA, Sterile Pkgd.
• 00841731109347: Half Pin, Orthex 4.5x200x10 Button HA, Sterile Pkgd
• 00841731109330: Half Pin, Orthex 3.0x200x50 Button HA, Sterile Pkgd
• 00841731109323: Half Pin, Orthex 3.0x200x45 Button, HA, Sterile Pkgd.
• 00841731109316: Half Pin, Orthex 3.0x200x40 Button HA, Sterile Pkgd
• 00841731109309: Half Pin, Orthex 3.0x200x35 Button, HA, Sterile Pkgd.
• 00841731109293: Half Pin, Orthex 3.0x200x30 Button HA, Sterile Pkgd
• 00841731109286: Half Pin, Orthex 3.0x200x25 Button, HA, Sterile Pkgd.
• 00841731109279: Half Pin, Orthex 3.0x200x20 Button HA, Sterile Pkgd