Embrace Pen Needle 29G @12mm SHN02MM29.12

GUDID 00894030002109

Insulin pen needle 29G 12mm 100 ct.

OMNIS HEALTH, LLC

Autoinjector needle

• Primary Device ID: 00894030002109
• NIH Device Record Key: 3430ff1c-7132-41a5-b789-f7d73bc69570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embrace Pen Needle 29G @12mm
• Version Model Number: SHN02MM29.12
• Catalog Number: SHN02MM29.12
• Company DUNS: 824763358
• Company Name: OMNIS HEALTH, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• 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	00894030002109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193422

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: 2022-12-07
• Device Publish Date: 2022-11-29

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• 00894030002109 - Embrace Pen Needle 29G @12mm: 2022-12-07Insulin pen needle 29G 12mm 100 ct.
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