EasyPoint® 82091

GUDID 00613703820921

25G x 5/8" EasyPoint® Needle

RETRACTABLE TECHNOLOGIES, INC.

Hypodermic needle, single-use

• Primary Device ID: 00613703820921
• NIH Device Record Key: d9a702d5-5eb2-4afc-b941-6dcc56b29578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyPoint®
• Version Model Number: 82091
• Catalog Number: 82091
• Company DUNS: 838024255
• Company Name: RETRACTABLE TECHNOLOGIES, 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: true
• 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: false

Customer Support Contacts

• Phone: 888-703-1010
• Email: rtiservice@vanishpoint.com
• Phone: 888-703-1010
• Email: rtiservice@vanishpoint.com
• Phone: 888-703-1010
• Email: rtiservice@vanishpoint.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613703820907 [Primary]
GS1	00613703820914 [Package]; Contains: 00613703820907; Package: Box [50 Units]; In Commercial Distribution
GS1	00613703820921 [Package]; Contains: 00613703820914; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133635

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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-22

On-Brand Devices [EasyPoint®]

• 00613703820921: 25G x 5/8" EasyPoint® Needle
• 00613703820327: 23G x 1" EasyPoint® Needle
• 00613703820129: 25G x 1" EasyPoint® Needle
• 00613703852915: 25G x 5/8" EasyPoint® Needle
• 00613703852311: 23G x 1" EasyPoint® Needle
• 00613703852113: 25G x 1" EasyPoint® Needle
• 00613703850911: 18G x 1 1/2" EasyPoint® Needle
• 00613703850812: 18G x 1" EasyPoint® Needle
• 00613703850713: 20G x 1 1/2" EasyPoint® Needle
• 00613703850614: 20G x 1" EasyPoint® Needle
• 00613703850515: 21G x 1 1/2" EasyPoint® Needle
• 00613703850416: 21G x 1" EasyPoint® Needle
• 00613703850317: 22G x 1 1/2" EasyPoint® Needle
• 00613703850218: 22G x 1" EasyPoint® Needle
• 00613703850119: 25G x 1 1/2" EasyPoint® Needle
• 00613703822116: 30G x 1/2" EasyPoint® Needle
• 00613703260215: 21G x 1 1/4" EasyPoint® Blood Collection Tube Holder with Needle
• 00613703260116: 22G x 1 1/4" EasyPoint® Blood Collection Tube Holder with Needle