TrenGuard™

GUDID 00811836030440

TrenGuard 450 Solo Wedge Packs - 12 Each disposable packs (each pack includes one wedge bolster)

Dan Allen Surgical LLC

Operating table torso positioner

• Primary Device ID: 00811836030440
• NIH Device Record Key: b7f33640-3a89-4cf6-bd20-3191cf6358c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrenGuard™
• Version Model Number: 54612
• Company DUNS: 040876183
• Company Name: Dan Allen Surgical LLC
• Device Count: 12
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811836030440 [Primary]
GS1	00811836030884 [Unit of Use]

FDA Product Code

• CCX: Support, Patient Position

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: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [TrenGuard™]

• 00811836030891: TrenGuard Patient Support Frame Bariatric - For use with TrenGuard Packs and accessories.
• 00811836030846: TrenGuard 600 Solo Wedge Packs - 12 each disposable packs (each pack includes one wedge bolster
• 00811836030440: TrenGuard 450 Solo Wedge Packs - 12 Each disposable packs (each pack includes one wedge bolster