Biotronix Healthcare Syringes GE12011

GUDID 00858835007394

Disposable .30CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use

• Primary Device ID: 00858835007394
• NIH Device Record Key: 20e5e97d-9ed8-48a6-824e-b72d80fcab1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare Syringes
• Version Model Number: GE12011
• Catalog Number: GE12011
• 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: true

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	00858835007370 [Primary]
GS1	00858835007387 [Package]; Contains: 00858835007370; Package: Inner Box [10 Units]; In Commercial Distribution
GS1	00858835007394 [Package]; Contains: 00858835007387; 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: 2019-10-12

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