Needle, Hypodermic, Single Lumen

GUDID 00816513020141

MPS MEDICAL, INC

Hypodermic needle, single-use

• Primary Device ID: 00816513020141
• NIH Device Record Key: 33deec0a-c94e-4f78-89d9-5dbf39f5b7cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle, Hypodermic, Single Lumen
• Version Model Number: 19B
• Company DUNS: 079636164
• Company Name: MPS MEDICAL, INC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816513020141 [Primary]
GS1	10816513020148 [Package]; Package: BOX [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972538

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-05-23

On-Brand Devices [Needle, Hypodermic, Single Lumen]

• 00816513020295: 900490
• 00816513020158: 19B-B
• 00816513020141: 19B