SureFine Pen Needle 31GX5mm

GUDID 08800052600652

SureFine Pen Needle 31GX5mm 100pcs per Box

SHINA MED CORPORATION

Autoinjector needle

• Primary Device ID: 08800052600652
• NIH Device Record Key: 8fdf67ff-bbe4-45d2-a96e-5d922a8cdc06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureFine Pen Needle 31GX5mm
• Version Model Number: SM-0017
• Company DUNS: 689061990
• Company Name: SHINA MED CORPORATION
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800052600638 [Primary]
GS1	08800052600645 [Package]; Contains: 08800052600638; Package: Case [10 Units]; In Commercial Distribution
GS1	08800052600652 [Package]; Contains: 08800052600645; Package: Master Case [6 Units]; In Commercial Distribution
GS1	8800052600638 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152877

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

[08800052600652]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

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