Tube Guard

GUDID B064HB11200101

XENCO MEDICAL LLC

Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use Endoscopic bite block, basic, single-use

• Primary Device ID: B064HB11200101
• NIH Device Record Key: dcc397f0-8123-4f13-b5b8-4f29b958921c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube Guard
• Version Model Number: HB-112-0010
• Company DUNS: 079282130
• Company Name: XENCO MEDICAL LLC
• 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: 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
HIBCC	B064HB11200101 [Primary]

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

Devices Manufactured by XENCO MEDICAL LLC

• B064HB11200101 - Tube Guard: 2023-08-15
• B064HB11200101 - Tube Guard: 2023-08-15
• B064MPE010101 - Saratoga Cervical Brace: 2023-08-15
• B064MPE010401 - Tahiti Lumbar Brace: 2023-08-15
• B064XM11510001 - Pedicle Screw Instruments Kit: 2022-08-19
• B064XM12323451 - 23mm x 10mm PLIF Trial Kit 12, 13, 14, 15 mm Heights: 2020-04-06 23mm x 10mm PLIF Trials: 12, 13, 14, 15 mm Heights
• B064XM12723451 - 27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights: 2020-04-06 27mm x 12mm TLIF Trials: 12, 13, 14, 15 mm Heights
• B064XM12789011 - 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights: 2020-04-06
• B064XM12823451 - 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights: 2020-04-06 28mm x 11mm Oblique Trial Kit 12, 13, 14, 15 mm Heights