PurCel Labs Safety Insulin Pen Needles (32G x 4mm)

GUDID 10810143550402

Insulin Safety Pen Needle, Sterile, Single Use, 32G x 4mm, (100/Box).

Purcel Labs LLC

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• Primary Device ID: 10810143550402
• NIH Device Record Key: 6b78e987-9379-4e13-8e34-098e9b7e78c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PurCel Labs Safety Insulin Pen Needles (32G x 4mm)
• Version Model Number: 1086-100
• 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	00810143550405 [Primary]
GS1	00810143550467 [Package]; Contains: 00810143550405; Package: Inner Case [10 Units]; In Commercial Distribution
GS1	00810143550474 [Package]; Contains: 00810143550467; Package: Shipping Case [6 Units]; In Commercial Distribution
GS1	10810143550402 [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

• 10810143550402 - PurCel Labs Safety Insulin Pen Needles (32G x 4mm): 2023-08-28Insulin Safety Pen Needle, Sterile, Single Use, 32G x 4mm, (100/Box).
• 10810143550402 - PurCel Labs Safety Insulin Pen Needles (32G x 4mm): 2023-08-28 Insulin Safety Pen Needle, Sterile, Single Use, 32G x 4mm, (100/Box).
• 00810143550481 - PurCel Labs Safety Insulin Pen Needles (31G x 5mm): 2023-08-28 Insulin Safety Pen Needle, Sterile, Single Use, 31G x 5mm, (100/Box).
• 00810143550504 - PurCel Labs Safety Insulin Pen Needles (30G x 6mm): 2023-08-28 Insulin Safety Pen Needle, Sterile, Single Use, 30G x 6mm, (100/Box).
• 00810143550788 - PurCel Labs ASTM Level 1 Surgical Masks: 2023-08-28 ASTM Level 1 Surgical Masks, Non-Sterile, Single Use, Ear-loop, Blue, (50/Box).
• 00810143550801 - PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks: 2023-08-28 Individually Wrapped, ASTM Level 1 Surgical Masks, Non-Sterile, Single Use, Ear-loop, Blue, (50/Box).
• 00810143550580 - PurCel Labs Small 4 MIL Black Exam Gloves: 2023-08-23 Black Nitrile Exam Gloves, Size Small, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Ste
• 00810143550610 - PurCel Labs Medium 4 MIL Black Exam Gloves: 2023-08-23 Black Nitrile Exam Gloves, Size Medium, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-St
• 00810143550641 - PurCel Labs Large 4 MIL Black Exam Gloves: 2023-08-23 Black Nitrile Exam Gloves, Size Large, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Ste