BD Ultra-Fine Pen Needles, 31G x 8MM 320109

GUDID 50382903201094

PEN NDL 31GA 8MM 100 BX 1200 USA

BECTON DICKINSON PEN LIMITED

Autoinjector needle

• Primary Device ID: 50382903201094
• NIH Device Record Key: d9a884c9-dc0a-417e-8f33-9309ce351f13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Ultra-Fine Pen Needles, 31G x 8MM
• Version Model Number: 320109
• Catalog Number: 320109
• Company DUNS: 988402590
• Company Name: BECTON DICKINSON PEN LIMITED
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382900109091 [Unit of Use]
GS1	00382903201099 [Primary]
GS1	50382903201094 [Package]; Contains: 00382903201099; Package: Case [12 Units]; In Commercial Distribution
GS1	80382903201095 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131358
• Premarket Notification: K213478

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-03

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