CarePoint Precision

GUDID 00786227221076

21G x 1" Poly Hub Needle

ALLISON MEDICAL, INC.

Hypodermic needle, single-use

• Primary Device ID: 00786227221076
• NIH Device Record Key: 935d3de9-7d65-44e7-a55b-e5a0f8cf83e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CarePoint Precision
• Version Model Number: 202-2101
• Company DUNS: 825097264
• Company Name: ALLISON MEDICAL, INC.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch
• Needle Gauge: 21 Gauge
• Length: 1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00786227221014 [Unit of Use]
GS1	00786227221052 [Primary]
GS1	00786227221076 [Package]; Contains: 00786227221052; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124037

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2023-12-07
• Device Publish Date: 2023-11-29

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• 00786227053271: 3ml Luer Lock Syringe w/ 20G x 1.5"
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