GNP

GUDID 00357515710055

8mm pen needle UltiGuard

Amerisourcebergen Drug Corporation

Autoinjector needle

• Primary Device ID: 00357515710055
• NIH Device Record Key: f725bff6-1b84-47a0-87c6-c48cfc547ece
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GNP
• Version Model Number: 09583GNP
• 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	00087701434341 [Primary]
GS1	00357515710055 [Unit of Use]
GS1	20041220678048 [Primary]

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: 2022-09-08
• Device Publish Date: 2022-08-31

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