GNP

GUDID 00087701434280

5mm pen needle UltiGuard

AMERISOURCEBERGEN DRUG CORPORATION

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle 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