SUSTOL Co-packaged Kit

GUDID 00347426101066

SUSTOL Co-packaged Kit

Heron Therapeutics, Inc.

Syringe-loaded medication/vaccine injector, manual, professional

• Primary Device ID: 00347426101066
• NIH Device Record Key: 37d52ccb-5a77-4dfd-af77-43c05a0a7a00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUSTOL Co-packaged Kit
• Version Model Number: NA
• Company DUNS: 102099843
• Company Name: Heron Therapeutics, Inc.
• 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: false
• 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	00347426101066 [Primary]

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: 2025-03-26
• Device Publish Date: 2025-03-18

Devices Manufactured by Heron Therapeutics, Inc.

• 00347426101066 - SUSTOL Co-packaged Kit: 2025-03-26SUSTOL Co-packaged Kit
• 00347426101066 - SUSTOL Co-packaged Kit: 2025-03-26 SUSTOL Co-packaged Kit
• 00347426505086 - ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement: 2024-11-15 ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
• 00347426506083 - ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement: 2024-11-15 ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement
• 00347426505079 - ZYNRELEF 10 mL Vial Access Needle (VAN): 2024-10-10 ZYNRELEF 10 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
• 00347426506076 - ZYNRELEF 20 mL Vial Access Needle (VAN): 2024-10-10 ZYNRELEF 20 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
• 00347426902106 - ZYNRELEF Luer Lock Applicator: 2021-07-23
• 00347426903059 - ZYNRELEF Replacement Vented Vial Spikes: 2021-07-23 Base package contains quantity of 5 vented vial spikes.
• 00347426904087 - ZYNRELEF Replacement 12 mL Luer Lock Syringes: 2021-07-23 Base package contains quantity of 8 of the 12 mL Luer Lock Syringes.