Pediatric Stylet 90201

GUDID 10859290006356

The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.

TRUER MEDICAL, INC.

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• Primary Device ID: 10859290006356
• NIH Device Record Key: 59c03680-6d14-4158-ac5e-472d83baed4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Stylet
• Version Model Number: 90201
• Catalog Number: 90201
• Company DUNS: 003530786
• Company Name: TRUER MEDICAL, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com
• Phone: 7146289785
• Email: ttruitt@truermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006359 [Primary]
GS1	10859290006356 [Package]; Contains: 00859290006359; Package: Carton [20 Units]; In Commercial Distribution
GS1	20859290006353 [Package]; Contains: 00859290006359; Package: Carton [25 Units]; In Commercial Distribution
GS1	30859290006350 [Package]; Package: Carton [5 Units]; In Commercial Distribution
GS1	40859290006357 [Package]; Package: Carton [25 Units]; In Commercial Distribution

FDA Product Code

• BSR: Stylet, 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: 2022-07-08
• Device Publish Date: 2022-06-30

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