TORS

GUDID 00842102115820

Mouth Guard with Hex Post

FLEXBAR MACHINE CORPORATION

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

• 00842102116247 - StrongArm Surgical Holders and Positioners: 2025-05-13 StrongArm, Single w/Short Distal Arm, QC Fitting, Long Post (no Rail clamp)
• 00842102116230 - Flexarm Surgical Holders and Positioners: 2025-05-07 Mirus Table Clamp
• 00842102116193 - Bookler Table Mounted Retractor Systems: 2025-05-02 Blade, Wylie Renal Vein, Malleable 1 x 4 1/2" (2.5 x 11.4)
• 00842102116209 - Bookler Table Mounted Retractor Systems: 2025-05-02 Blade, Wylie Renal Vein, Malleable 1 x 6" (2.5 x 15.2cm)
• 00842102116216 - StrongArm Surgical Holders and Positioners: 2025-05-02 StrongArm Single Arm w/ Short Distal Arm QC Fitting, Rail Clamp
• 00842102116223 - Bookler Table Mounted Retractor Systems: 2025-05-02 Mini-Bookler Elevating Ratchet
• 00842102116179 - Flexarm Surgical Holders and Positioners: 2025-02-24 Bronchoscope Flexible Holding Arm, Mount Post with Rail Clamp & Storage Case
• 00842102116186 - Flexarm Surgical Holders and Positioners: 2025-02-24 Mount Post with Rail Clamp for Bronchoscope Flexible Holding Arm