FDA.reportPublic FDA data

GBUK

Primary DI
16971911299078
Brand
GBUK
Company
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Model
1
Device description
Hypodermic Needle 23G*1"
Published
2021-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971911299078PackageGS1100In Commercial Distribution
26971911299075PackageGS110000In Commercial Distribution
06971911299071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697191129907816971911299078
2697191129907526971911299075
06971911299071069719112990716971911299071

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
554400604
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971911292550micsafe 12023-05-31
16971911292567micsafe 12023-05-31
06971911290726micsafe 12023-05-31
06971911290733micsafe 12023-05-31
06971911290740micsafe 12023-05-31
06971911290757micsafe 12023-05-31
06971911290764micsafe 12023-05-31
06971911290771micsafe 12023-05-31
06971911291075micsafe 12023-05-31
06971911291082micsafe 12023-05-31
06971911291174micsafe 12023-05-31
06971911291181micsafe 12023-05-31
06971911291198micsafe 12023-05-31
06971911291501micsafe 12023-05-31
06971911291518micsafe 12023-05-31
06971911291525micsafe 12023-05-31
06971911291532micsafe 12023-05-31
06971911291556micsafe 12023-05-31
06971911291563micsafe 12023-05-31
06971911291570micsafe 12023-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08800145524667JBP Nanocannula 23Gx40mmFeeltech Co.,Ltd.FMI2026-04-16
08800052609242Sure Fine Pen Needle 32G x 4mmSHINA MED CORPORATIONFMI2026-03-25
08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571455SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571479SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571493SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571516SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049637SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-02
08586015049699SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-02
08586026571189SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-02
08586026571202SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-02