TopCare Insulin Syringe

GUDID 10036800250823

.3cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct

Topco Associates, LLC

Insulin syringe/needle, basic

• Primary Device ID: 10036800250823
• NIH Device Record Key: 7bb45388-7d70-4a3b-aa13-047d8c7928fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopCare Insulin Syringe
• Version Model Number: 033108
• Company DUNS: 072943876
• Company Name: Topco Associates, LLC
• 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: true

Device Dimensions

• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Total Volume: 0.3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036800250826 [Primary]
GS1	10036800250823 [Package]; Contains: 00036800250826; Package: Shipper [30 Units]; In Commercial Distribution
GS1	10070030510722 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062702

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-18
• Device Publish Date: 2016-09-24

On-Brand Devices [TopCare Insulin Syringe]

• 10036800250847: 1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250830: .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250823: .3cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250816: 1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250809: .5cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250793: .3cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250786: 1cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250779: .5cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct
• 10036800250762: .3cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct