FDA.report

GBUK

Primary DI
16971911299252
Brand
GBUK
Company
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Model
1
Device description
Hypodermic Needle 26G*3/8"
Published
2021-05-20
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

Related Records

Product Codes

CodeName
MEGSyringe, Antistick

Product Code Classifications

CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16971911299252PackageGS1100In Commercial Distribution
26971911299259PackageGS110000In Commercial Distribution
06971911299255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1697191129925216971911299252
2697191129925926971911299259
06971911299255069719112992556971911299255

GMDN Terms

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

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 DIBrandModelCatalogPublished
16971911290723micsafe 12023-05-31
16971911290730micsafe 12023-05-31
16971911290747micsafe 12023-05-31
16971911290754micsafe 12023-05-31
16971911290761micsafe 12023-05-31
16971911290778micsafe 12023-05-31
16971911291072micsafe 12023-05-31
16971911291089micsafe 12023-05-31
06971911291099BIAL12023-05-31
06971911291105BIAL12023-05-31
06971911291112BIAL12023-05-31
06971911291129BIAL12023-05-31
06971911291143BIAL12023-05-31
06971911291150BIAL12023-05-31
06971911291167BIAL12023-05-31
16971911291171micsafe 12023-05-31
16971911291188micsafe 12023-05-31
16971911291195micsafe 12023-05-31
16971911291508micsafe 12023-05-31
16971911291515micsafe 12023-05-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20850083784274Comfort EZS.D.I. USA, INC.MEG2026-02-13
20850083784328Comfort EZS.D.I. USA, INC.MEG2026-02-13
MHC14233250EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14251160EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14251250EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14301060EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14301080EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14305060EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
MHC14305080EasyTouchMHC MEDICAL PRODUCTS, LLCMEG2026-01-07
09347144013109Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
00613703101419VanishPoint®RETRACTABLE TECHNOLOGIES, INC.MEG2025-06-08
30382903059301SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
50382903059329SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
50382903059343SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
30382903059356SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
30382903059370SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
50382903284462SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
50382903284479SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
30382903284499SafetyGlide Insulin SyringeBECTON, DICKINSON AND COMPANYMEG2025-05-09
10812460024765Rospital Producos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460024772Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460024789Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460026240Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460026271Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
10812460026295Rospital Productos MedicosATLAS MEDICAL PRODUCTS LLCMEG2024-04-16
00810008214527ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm)MediVena, LLCMEG2024-02-26
20612479268719McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
20612479268740McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
40612479260823McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
40612479260854McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27