GNP

GUDID 00087701434280

5mm pen needle UltiGuard

AMERISOURCEBERGEN DRUG CORPORATION

Autoinjector needle

• Primary Device ID: 00087701434280
• NIH Device Record Key: 2accf344-37aa-4894-a970-0ea8ee7592c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GNP
• Version Model Number: 09553GNP
• Company DUNS: 007914906
• Company Name: AMERISOURCEBERGEN DRUG 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00087701434280 [Package]; Contains: 00087701434327; Package: UltiGuard [1 Units]; In Commercial Distribution
GS1	00087701434327 [Primary]
GS1	00357515710130 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100812

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: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [GNP ]

• 00087701434303: 8mm pen needle UltiGuard
• 00087701434297: 6mm 32G pen needle UltiGuard
• 00087701434280: 5mm pen needle UltiGuard
• 00357515710055: 8mm pen needle UltiGuard