PurCel Labs Safety Insulin Pen Needles (30G x 6mm)

GUDID 00810143550504

Insulin Safety Pen Needle, Sterile, Single Use, 30G x 6mm, (100/Box).

Purcel Labs LLC

Autoinjector needle

• Primary Device ID: 00810143550504
• NIH Device Record Key: 0a0a065b-2609-43f7-9a18-0638532575df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PurCel Labs Safety Insulin Pen Needles (30G x 6mm)
• Version Model Number: 1088-100
• Company DUNS: 127672531
• Company Name: Purcel Labs LLC
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810143550443 [Primary]
GS1	00810143550504 [Package]; Contains: 00810143550443; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	00810143550511 [Package]; Package: Shipping Case [6 Units]; In Commercial Distribution
GS1	10810143550440 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213183

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: 2
• Public Version Date: 2023-08-28
• Device Publish Date: 2023-08-08

Devices Manufactured by Purcel Labs LLC

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