FDA.reportPublic FDA data

SOL-Guard Safety Needle

Primary DI
16958697600373
Brand
SOL-Guard Safety Needle
Company
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Model
21G x 1"
Catalog number
SND491
Device description
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.
Published
2021-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190183000Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2019-10-04MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16958697600373PackageGS1100In Commercial Distribution
26958697600370PackageGS110In Commercial Distribution
06958697600376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695869760037316958697600373
2695869760037026958697600370
06958697600376069586976003766958697600376

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543007373
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16958697622214One+Step INSULIN PEN NEEDLE"32G×5/32"" RWLB"2026-05-15
06958697621555Blood Collection Needle without Needle Holder"25G × 3/4"" RWSB"2026-03-26
06958697621562Blood Collection Needle without Needle Holder"24G × 1"" TWSB"2026-03-26
06958697621579Blood Collection Needle without Needle Holder"23G × 1 1/8"" TWSB"2026-03-26
06958697621586Blood Collection Needle without Needle Holder"22G × 1 1/4"" TWSB"2026-03-26
06958697621593Blood Collection Needle without Needle Holder"21G × 1 1/4"" TWLB"2026-03-26
06958697621609Blood Collection Needle without Needle Holder"20G × 1 2/5"" TWLB"2026-03-26
06958697621616Blood Collection Needle without Needle Holder"19G × 1 1/2"" TWLB"2026-03-26
06958697621623Blood Collection Needle without Needle Holder"18G × 1 1/2"" TWLB"2026-03-26
06958697621630Blood Collection Needle with Needle Holder"25G × 3/4"" RWSB"2026-03-26
06958697621647Blood Collection Needle with Needle Holder"24G × 5/8"" TWSB"2026-03-26
06958697621654Blood Collection Needle with Needle Holder"23G × 1 1/8"" TWSB"2026-03-26
06958697621661Blood Collection Needle with Needle Holder"22G × 1 1/4"" TWSB"2026-03-26
06958697621678Blood Collection Needle with Needle Holder"21G × 1 1/4"" TWLB"2026-03-26
06958697621685Blood Collection Needle with Needle Holder"20G × 1 2/5"" TWLB"2026-03-26
06958697621692Blood Collection Needle with Needle Holder"19G × 1 1/2"" TWLB"2026-03-26
06958697621708Blood Collection Needle with Needle Holder"18G × 1 1/2"" TWLB"2026-03-26
06958697621715INSULIN PEN NEEDLE34G x 4mm RWLB2026-03-26
06958697621722INSULIN PEN NEEDLE33G x 5mm RWLB2026-03-26
06958697621739INSULIN PEN NEEDLE32G x 6mm RWLB2026-03-26

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