Biotronix Healthcare Syringes GE12004

GUDID 20858835007190

Disposable 1cc Insulin Unibody Syringe, U-100, W/Needle 31G x 5/16"

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use

• Primary Device ID: 20858835007190
• NIH Device Record Key: f0826dfc-7907-4c85-9363-4bc8fb08fd33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare Syringes
• Version Model Number: GE12004
• Catalog Number: GE12004
• Company DUNS: 065762392
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858835007196 [Primary]
GS1	10858835007193 [Package]; Contains: 00858835007196; Package: Inner Box [100 Units]; In Commercial Distribution
GS1	20858835007190 [Package]; Contains: 10858835007193; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110421

FDA Product Code

• FMF: Syringe, Piston

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: 2019-12-24
• Device Publish Date: 2019-10-10

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