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

• 00842102116124 - Bookler Table Mounted Retractor Systems: 2024-12-27 Bookler Blade, Slotted Malleable, 3 x 6 1/2" (7.6 x 16.5cm)
• 00842102116131 - Bookler Table Mounted Retractor Systems: 2024-12-27 Bookler Blade, Slotted Malleable, 2 x 6 1/2" (5.1 x 16.5cm)
• 00842102116148 - Bookler Table Mounted Retractor Systems: 2024-12-27 Blade, Malleable, 3 x 6" - no protective edge
• 00842102116155 - Bookler Table Mounted Retractor Systems: 2024-12-27 Blade, Malleable, 2 x 6" - no protective edge
• 00842102116162 - Bookler Table Mounted Retractor Systems: 2024-12-27 Blade, Malleable 1 1/2” x 6 1/2” - no protective edge
• 10842102116107 - TAS Medical, Inc. ZipClip: 2024-12-19 ZipClip Hook Scissor Tip, Disposable, Sterile
• 00842102116117 - TAS Medical, Inc. ZipGrip: 2024-12-19 ZipGrip Handle w/Insulated Shaft, 5mm x 33 cm
• 00842102116087 - StrongArm Surgical Holders and Positioners: 2024-11-08 Bronchoscope Dual Stabilization System with rigid arm, fixed Tip and Mount Post with Flexible Arm, fixed Tip incl. Rail Clamp &