H.E.B. Unifine Pentips Plus

GUDID 00384703890008

HEB Unifine Pentips Plus pen needles, 6mm x 31G

H. E. BUTT GROCERY COMPANY

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: 00384703890008
• NIH Device Record Key: 1e118dc8-da43-4159-921a-d46fb37f45e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.E.B. Unifine Pentips Plus
• Version Model Number: AN 3891HEB
• Company DUNS: 007924756
• Company Name: H. E. BUTT GROCERY COMPANY
• Device Count: 50
• 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: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter
• Needle Gauge: 32 Gauge
• Length: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041220520978 [Primary]
GS1	00384703890008 [Unit of Use]

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 Plus]

• 30041220940753: HEB Unifine Pentips Plus pen needle 4mm x 33G
• 00384703890008: HEB Unifine Pentips Plus pen needles, 6mm x 31G
• 50041220520867: HEB Unifine Pentips Plus pen needles, 5mm x 31G
• 50041220520829: HEB Unifine Pentips Plus pen needles, 4mm x 32G
• 50041220520683: HEB Unifine Pentips Plus pen needles, 8mm x 31G
• 30041220520665: HEB Unifine Pentips Plus pen needles, 8mm x 31G
• 50041220520379: HEB Unifine Pentips Plus pen needles, 6mm x 31G
• 30041220520368: HEB Unifine Pentips Plus pen needle, 6mm x 31G