Disposable Sclerotherapy Needle

GUDID 00813353010226

Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length

Telemed Systems

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• Primary Device ID: 00813353010226
• NIH Device Record Key: fdf0e554-2014-48e9-aa26-9b430e2a3aae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sclerotherapy Needle
• Version Model Number: 2008
• 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	00813353010226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901437

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

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

On-Brand Devices [Disposable Sclerotherapy Needle]

• 00813353010271: Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length
• 00813353010264: Sure-Stop Sclerotherapy Needle 23GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length
• 00813353010257: Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length
• 00813353010240: Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length
• 00813353010233: Sure-Stop Sclerotherapy Needle 21GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length
• 00813353010226: Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length
• 00813353010219: Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length
• 00813353010202: Sure-Stop Sclerotherapy Needle 23GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length
• 00813353010196: Sure-Stop Sclerotherapy Needle 23GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length