H.E.B. Unifine Pentips

GUDID 30041220981336

HEB Unifine Pentips Plus pen needles, 5mm x 31G

H. E. BUTT GROCERY COMPANY

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• Primary Device ID: 30041220981336
• NIH Device Record Key: acaa7a14-5017-4750-8f4f-6f39cbf4df8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.E.B. Unifine Pentips
• Version Model Number: AN 3550HEB
• Company DUNS: 007924756
• Company Name: H. E. BUTT GROCERY COMPANY
• 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

• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041220981335 [Primary]
GS1	00384703550001 [Unit of Use]
GS1	30041220981336 [Package]; Contains: 00041220981335; Package: Sleeve [10 Units]; In Commercial Distribution
GS1	50041220981330 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152339

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: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [H.E.B. Unifine Pentips ]

• 00384703550001: HEB Unifine Pentips, 8mm x 31G
• 30041220981336: HEB Unifine Pentips Plus pen needles, 5mm x 31G
• 00384703590007: HEB Unifine Pentips pen needles, 6mm x 31G