ONETRAC LXS C110220

GUDID M648C1102201

ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE

OBP CORPORATION

Surgical/emergency suction cannula, illuminating, single-use

• Primary Device ID: M648C1102201
• NIH Device Record Key: edb3d261-10ad-4e8f-8006-1545969c9d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONETRAC LXS
• Version Model Number: C110220
• Catalog Number: C110220
• Company DUNS: 011560431
• Company Name: OBP CORPORATION
• Device Count: 1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M648C1102200 [Primary]
HIBCC	M648C1102201 [Package]; Contains: M648C1102200; Package: unit box [1 Units]; In Commercial Distribution
HIBCC	M648C1102202 [Package]; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• JOL: Catheter And Tip, Suction

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: 2022-04-25
• Device Publish Date: 2022-04-15

On-Brand Devices [ONETRAC LXS]

• M648C1102001: ONETRAC LXS SUCTION, CROWN TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE
• M648C1102201: ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE
• M648C1102101: ONETRAC LXS SUCTION, METAL TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE