SonoTip II EBUS Flex GUS-22-18-022

GUDID 04052838011105

SonoTip II EBUS Flex with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Styl

Medi-Globe GmbH

Body aspiration needle, single-use

• Primary Device ID: 04052838011105
• NIH Device Record Key: 0ddb388a-eb15-446c-b2b2-116cdfb47209
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoTip II EBUS Flex
• Version Model Number: GUS-22-18-022
• Catalog Number: GUS-22-18-022
• Company DUNS: 318130267
• Company Name: Medi-Globe GmbH
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4980329730
• Email: sales@medi-globe.de

Device Dimensions

• Needle Gauge: 22 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052838011105 [Package]; Contains: 04052838011112; Package: Box [5 Units]; In Commercial Distribution
GS1	04052838011112 [Primary]

FDA Product Code

• FCG: Biopsy Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-30

Devices Manufactured by Medi-Globe GmbH

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• 4052838014151 - SonoTip Pro Control: 2018-12-21 SonoTip ProControl Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath Diameter 1.8 mm, round stylet
• 04052838009423 - Injectra, ScleroTip: 2018-03-29 Injection Needle / Slerotherapy Needle , 22 Gauge, needle length 4 mm, tube diameter 1.9 mm, working length 230 cm
• 04052838009560 - Injectra, ScleroTip: 2018-03-29 Injection Needle / Sclerotherapy Needle, 22 Gauge, needle length 6 mm, tube diameter 1.9 mm, working length 230 cm
• 04052838011082 - SonoTip II EBUS: 2018-03-29 SonoTip II EBUS-TBNA Neelde-System for Pentax Endoscope, 22 Gauge needle, round Nitinol stylet, needle ø 0.7 mm, outer ø 1.8 m
• 04052838011105 - SonoTip II EBUS Flex: 2018-03-29SonoTip II EBUS Flex with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Styl
• 04052838011105 - SonoTip II EBUS Flex: 2018-03-29 SonoTip II EBUS Flex with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle Syst
• 04052838011440 - SonoTip® EBUS Pro Flex: 2018-03-29 SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System,
• 04052838011464 - SonoTip® EBUS Pro: 2018-03-29 SonoTip EBUS Pro with Stainless Steel Needle, Endobronchial Ultrasound Guided TBNA System for Olympus Endoscope, 22 Gauge Needle