162054

GUDID ETDG162054

Sterile Suction Needles (Endo Evacuation Needles) are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site during oral surgery. The device is a semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, irrigating solutions and water during a dental or oral procedure. Suction Needles are to be locked on a Luer Lock connection. It is not intended to penetrate tissue (it is not an injection needle). The cannula is made of stainless steel. This is a single-use device.

medmix Deutschland GmbH

Dental suction system cannula, single-use

• Primary Device ID: ETDG162054
• NIH Device Record Key: 4ec43874-d86e-40a2-9b8e-2bd26d6cbd50
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 27G 0.4 x 32 mm, Luer Lock, single apical side ven
• Catalog Number: 162054
• Company DUNS: 314320603
• Company Name: medmix Deutschland GmbH
• Device Count: 25
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ETDG162054 [Unit of Use]
HIBCC	ETDG1620542 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2024-09-23
• Device Publish Date: 2024-09-15

Devices Manufactured by medmix Deutschland GmbH

• ETDG186777 - NA: 2024-10-09 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG186778 - NA: 2024-10-09 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG186779 - NA: 2024-10-09 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG186780 - NA: 2024-10-09 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG1620622 - NA: 2024-09-25 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG1620632 - NA: 2024-09-25 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG1620642 - NA: 2024-09-25 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site
• ETDG1620652 - NA: 2024-09-25 Sterile Suction Needles are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site