FDA.reportPublic FDA data

MEDSUN

Primary DI
06934047910852
Brand
MEDSUN
Company
Ningbo Medsun Medical Co., Ltd.
Model
SDW 0.22mm(32.5G)×8mm
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K253622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253622000Safety Pen NeedleNingbo Medsun Medical Co., Ltd.2026-03-18FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934047910852PrimaryGS10
86934047910858Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934047910852069340479108526934047910852
8693404791085886934047910858

Regulatory Flags#

DUNS number
545194383
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934047910609MEDSUNDLM2026-04-22
06934047910616MEDSUNDLP2026-04-22
06934047910623MEDSUNDLN2026-04-22
06934047910630MEDSUNDLT2026-04-22
06934047910647MEDSUNELM2026-04-22
06934047910654MEDSUNELP2026-04-22
06934047910661MEDSUNELN2026-04-22
06934047910678MEDSUNELT2026-04-22
06934047910685MEDSUNSD 0.3mm(30G)×4mm2026-04-22
06934047910692MEDSUNSD 0.3mm(30G)×5mm2026-04-22
06934047910708MEDSUNSD 0.3mm(30G)×6mm2026-04-22
06934047910715MEDSUNSD 0.3mm(30G)×8mm2026-04-22
06934047910722MEDSUNSD 0.25mm(31G)×4mm2026-04-22
06934047910739MEDSUNSD 0.25mm(31G)×5mm2026-04-22
06934047910746MEDSUNSD 0.25mm(31G)×6mm2026-04-22
06934047910753MEDSUNSD 0.25mm(31G)×8mm2026-04-22
06934047910760MEDSUNSD 0.22mm(32.5G)×8mm2026-04-22
06934047910777MEDSUNSDW 0.3mm(30G)×4mm2026-04-22
06934047910784MEDSUNSDW 0.3mm(30G)×5mm2026-04-22
06934047910791MEDSUNSDW 0.3mm(30G)×6mm2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972857299474PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299481PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299498PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299504PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299511PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299528PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-04
16972857299467PEN TIPSSandstone Medical (Suzhou) Inc.FMI2026-11-03
00613703823106EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823304EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703823908EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853103EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853202EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853301EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853400EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853509EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853608EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853707EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853806EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00613703853905EasyPoint®RETRACTABLE TECHNOLOGIES, INC.FMI2026-11-02
00840216124264LiteTouchAsp Global, LLCFMI2026-11-02
00840216123793LiteTouchAsp Global, LLCFMI2026-10-30
00840216123823LiteTouchAsp Global, LLCFMI2026-10-30
00840216123847LiteTouchAsp Global, LLCFMI2026-10-30
00840216124288LiteTouchAsp Global, LLCFMI2026-10-30
05413206353712K-Pack IITerumo Europe NVFMI2026-10-28
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09