SonoTip II EBUS GUS-21-18-022

GUDID 04052838011082

SonoTip II EBUS-TBNA Neelde-System for Pentax Endoscope, 22 Gauge needle, round Nitinol stylet, needle ø 0.7 mm, outer ø 1.8 mm

Medi-Globe GmbH

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 04052838011082
• NIH Device Record Key: 475ed67e-c578-4ce3-815c-50758a26224f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoTip II EBUS
• Version Model Number: GUS-21-18-022
• Catalog Number: GUS-21-18-022
• 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

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	04052838011082 [Package]; Contains: 04052838011099; Package: Box [5 Units]; In Commercial Distribution
GS1	04052838011099 [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: 2017-01-31

Devices Manufactured by Medi-Globe GmbH

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• 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: 2018-03-29SonoTip II EBUS-TBNA Neelde-System for Pentax Endoscope, 22 Gauge needle, round Nitinol stylet, needle ø 0.7 mm, outer ø 1.8 mm
• 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: 2018-03-29 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