SOL-Guard Safety Needle SND475

GUDID 16958697600489

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 ID	16958697600489
NIH Device Record Key	2d6acba2-b174-476a-bb5d-fb9df57da8b8
Commercial Distribution Status	In Commercial Distribution
Brand Name	SOL-Guard Safety Needle
Version Model Number	25G x 1"
Catalog Number	SND475
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	06958697600482 [Primary]
GS1	16958697600489 [Package] Contains: 06958697600482 Package: [100 Units] In Commercial Distribution
GS1	26958697600486 [Package] Package: [10 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	2021-01-18
Device Publish Date	2021-01-08

On-Brand Devices [SOL-Guard Safety Needle]

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