SOL-Guard Safety Needle SND492

GUDID 16958697600007

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 ID16958697600007
NIH Device Record Key386f114f-145c-4eff-8ed5-0685845e8692
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOL-Guard Safety Needle
Version Model Number18G x 1 1/2"
Catalog NumberSND492
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
GS106958697600000 [Primary]
GS116958697600007 [Package]
Contains: 06958697600000
Package: [100 Units]
In Commercial Distribution
GS126958697600004 [Package]
Package: [10 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 Date2021-01-18
Device Publish Date2021-01-08

On-Brand Devices [ SOL-Guard Safety Needle]

16958697600427A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600007A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk

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