Safety Needle GL4765

GUDID 16958697602575

A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD

Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use

• Primary Device ID: 16958697602575
• NIH Device Record Key: 33378a9f-8210-45e8-bd6a-28270aa3390d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Needle
• Version Model Number: 25G X 1"
• Catalog Number: GL4765
• Company DUNS: 543007373
• Company Name: ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958697602578 [Primary]
GS1	16958697602575 [Package]; Contains: 06958697602578; Package: [100 Units]; In Commercial Distribution
GS1	26958697602572 [Package]; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190183

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-06

On-Brand Devices [Safety Needle]

• 16958697602353: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
• 16958697602346: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
• 16958697602339: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
• 16958697602322: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
• 16958697602506: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
• 16958697602483: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
• 16958697602575: A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk