TORS

GUDID 00842102115820

Mouth Guard with Hex Post

FLEXBAR MACHINE CORPORATION

Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable Mouth gag, non-adjustable

• Primary Device ID: 00842102115820
• NIH Device Record Key: c2758271-aaac-4bd8-8a39-b31161708740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TORS
• Version Model Number: 55000
• Company DUNS: 047644935
• Company Name: FLEXBAR MACHINE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842102115820 [Primary]

FDA Product Code

• KBN: Gag, Mouth

Sterilization

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

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

[00842102115820]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

Devices Manufactured by FLEXBAR MACHINE CORPORATION

• 00842102115844 - Holders and Positioners - Nathanson Hooks: 2024-04-25 Medium 6.5mm Nathanson Retractor, Cook-style, Robotic Shaft 9cm
• 00842102115837 - DynaTrac Retractor Frame: 2024-04-04 DynaTrac Retractor Frame, Square 7.4“ (18.8cm) x 7.4” (18.8cm)
• 00842102115820 - TORS: 2024-03-25Mouth Guard with Hex Post
• 00842102115820 - TORS: 2024-03-25 Mouth Guard with Hex Post
• 00842102115806 - Mediflex Universal Round Bar Table Mounted Retractor Systems: 2024-03-11 Detachable round bar short arm assembly - left
• 00842102115813 - Mediflex Universal Round Bar Table Mounted Retractor Systems: 2024-03-11 Detachable round bar short arm assembly - right
• 00842102115684 - Holders and Positioners - Nathanson Hooks: 2024-03-06 Large 6.5mm Nathanson Retractor, XL Tip
• 00842102115691 - Holders and Positioners - Nathanson Hooks: 2024-03-06 Medium 6.5mm Nathanson Retractor, XL Tip, Robotic Shaft 9cm
• 00842102115707 - Flexarm Surgical Holders and Positioners: 2024-03-06 FlexArm Dual Holder System