Takeda 101455

GUDID 00634188002046

1-Gallon Sharps Container - Flexible Petal Lid - Takeda

SHARPS COMPLIANCE CORP.

Sharps container

• Primary Device ID: 00634188002046
• NIH Device Record Key: 5ddb3e17-e3e7-4226-b7c1-b8bec794b3ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Takeda
• Version Model Number: 101455
• Catalog Number: 101455
• Company DUNS: 621667948
• Company Name: SHARPS COMPLIANCE CORP.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634188002046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083129

FDA Product Code

• MMK: Container, Sharps

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-06
• Device Publish Date: 2024-08-29

Devices Manufactured by SHARPS COMPLIANCE CORP.

• 00634188002046 - Takeda: 2024-09-061-Gallon Sharps Container - Flexible Petal Lid - Takeda
• 00634188002046 - Takeda: 2024-09-06 1-Gallon Sharps Container - Flexible Petal Lid - Takeda
• 00634188002022 - Sharps: 2024-05-01 3-Gallon Sharps Container - Flexible Petal Lid
• 00634188001742 - Sharps: 2023-03-17 1-Gallon Sharps Container - Standard
• 00634188001858 - Sharps: 2023-03-17 2-Gallon Sharps Container - Standard
• 00634188001865 - Sharps: 2023-03-17 3-Gallon Sharps Container - Standard
• 00634188001872 - Sharps: 2023-03-17 1-Quart Sharps Container - Standard
• 00634188001889 - Complete Needle: 2023-03-17 1-Quart Sharps Container - Complete Needle
• 00634188001896 - Sharps: 2023-03-17 2-Gallon Sharps Container - Flexible Petal Lid