FDA.reportPublic FDA data

PEN TIPS

Primary DI
16972857299498
Brand
PEN TIPS
Company
Sandstone Medical (Suzhou) Inc.
Model
01-3108
Published
2026-11-04
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36972857299492PackageGS1100In Commercial Distribution
16972857299498PrimaryGS10
06972857299491Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697285729949236972857299492
1697285729949816972857299498
06972857299491069728572994916972857299491

Regulatory Flags#

DUNS number
554500882
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972857299467PEN TIPS01-32042026-11-03
16972857299474PEN TIPS01-31052026-11-04
16972857299481PEN TIPS01-31062026-11-04
16972857299504PEN TIPS01-32052026-11-04
16972857299511PEN TIPS01-32062026-11-04
16972857299528PEN TIPS01-33042026-11-04
16972857299252Pen Needles04-31052026-09-24
06972857295677contour comfort Pen Needle04-32042026-08-19
16972857297784Easydrip Glider5 Classic Pro Pen Needles03-31052026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen Needles04-32042026-07-09
16972857295148Easydrip SafeGard Duo Safety Pen Needles05-30052025-07-08
16972857299290Easydrip Readygard Duo05-30052026-10-09
16972857299306Easydrip Readygard06-30052026-10-09
16972857299313Easydrip Readygard06-30082026-10-09
16972857299337Pen Needles Classic01-32042026-10-11
16972857296350MireMed PEN TIPS02-32042026-04-30
16972857296008Easydrip Pen Needles01-31082025-12-12
36972857296002Easydrip Pen Needles01-31082025-12-12
16972857295186Rapha Pen Needles01-32042025-07-31
16972857295193EveryMeds Pen Needles01-32042025-07-31

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
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
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07