BioCare Safety Needles BIO-1012S

GUDID 30858835007074

Disposable BioGuard Safety Needles 18G x 1 1/2",

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use

• Primary Device ID: 30858835007074
• NIH Device Record Key: eff1197b-71bf-4e10-a382-eaed3ffadfd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCare Safety Needles
• Version Model Number: BIO-1012S
• Catalog Number: BIO-1012S
• 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: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com
• Phone: 7864739436
• Email: mborges@biotronixhealthcare.com

Device Dimensions

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• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00858835007073 [Primary]
GS1	10858835007070 [Package]; Contains: 00858835007073; Package: INNER BOX [100 Units]; In Commercial Distribution
GS1	30858835007074 [Package]; Contains: 10858835007070; Package: CASE [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112057

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: 4
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-10-07

On-Brand Devices [BioCare Safety Needles]

• 20858835007770: Disposable BioCare Safety Needles 23G x 1 1/2"
• 20858835007763: Disposable BioCare Safety Needles 21G x 1 1/2"
• 20858835007756: Disposable BioCare Safety Needles 20G x 1 1/2"
• 20858835007114: Disposable BioCare Safety Needles 23G x 1"
• 20858835007091: Disposable BioCare Safety Needles 30G x 1/2"
• 20858835007084: Disposable BioCare Safety Needles 22G x 1 1/2"
• 30858835007074: Disposable BioGuard Safety Needles 18G x 1 1/2",