Disposable Transbronchial Needle

GUDID 00813353010288

Sure-Stop Transbronchial Aspiration Needle 21GA Needle Diameter x 1.8mm Sheath Diameter x 13mm Needle Length x 150cm Working Length

Telemed Systems

General-purpose endoscopic needle, single-use

• Primary Device ID: 00813353010288
• NIH Device Record Key: e525f923-e48b-4e1c-9ded-afb4b35f8650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Transbronchial Needle
• Version Model Number: 2102
• Company DUNS: 017939239
• Company Name: Telemed Systems
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813353010288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901438

FDA Product Code

• GAA: Needle, Aspiration And Injection, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-01
• Device Publish Date: 2023-08-24

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