SOL-Guard Safety Needle SND485

GUDID 16958697602254

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 Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use
Primary Device ID16958697602254
NIH Device Record Keya4c05fb5-ff43-4cad-9cd1-63aa6ba4399b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOL-Guard Safety Needle
Version Model Number27G x 1/2"
Catalog NumberSND485
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
GS106958697602257 [Primary]
GS116958697602254 [Package]
Contains: 06958697602257
Package: [100 Units]
In Commercial Distribution
GS126958697602251 [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]

16958697602278A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697602261A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697602254A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600502A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600496A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600489A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600472A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600465A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600458A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600441A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600434A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600410A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600403A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600397A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600380A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600373A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600366A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600359A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600342A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697600335A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697603046A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697603039A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697603022A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697603015A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697603008A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697602292A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk
16958697602285A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the sk

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.