Safety Needle 9760W631

GUDID 16958697602315

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
Primary Device ID16958697602315
NIH Device Record Key2751662e-3a5b-403f-8f27-a0ac819e7b31
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafety Needle
Version Model Number25G x 1''
Catalog Number9760W631
Company DUNS543007373
Company NameANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106958697602318 [Primary]
GS116958697602315 [Package]
Contains: 06958697602318
Package: [100 Units]
In Commercial Distribution
GS126958697602312 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-25
Device Publish Date2021-01-15

On-Brand Devices [ Safety Needle]

16958697602315A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697602308A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk

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