FDA.reportPublic FDA data

Doctors Choice

Primary DI
G018SN2301061
Brand
Doctors Choice
Company
Supply Line International Medical, LLC
Model
SN230106
Device description
Safety Needle, 23G x 1"
Published
2021-03-25
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191644000TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd.2020-08-06FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G018SN2301061PackageHIBCC100In Commercial Distribution
G018SN2301062PackageHIBCC20In Commercial Distribution
G018SN2301060PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079241502
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
true
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
G018P850DC1Physicians ChoiceP850DC2023-06-12
G018DCC020Physicians ChoiceDCC-022022-12-09
G018DLH010Physician's ChoiceDLH012021-08-05
G018SN2301060Doctors ChoiceSN2301062021-03-25
G018SN2315060Doctors ChoiceSN2315062021-03-25
G018SN2501060Doctors ChoiceSN2501062021-03-25
G018SN2515060Doctors ChoiceSN2515062021-03-25
G018DLH012Physician's ChoiceDLH012021-08-05
G018SND25G1504Doctors ChoiceSND25G15042021-06-09
G018SND25G150401Doctors ChoiceSND25G15042021-06-09
G018SYS01LL070Doctors ChoiceSYS01072021-04-20
G018SYS01060Doctors ChoiceSYS01062021-03-25
G018SYS03060Doctors ChoiceSYS03062021-03-25
G018SN2315061Doctors ChoiceSN2315062021-03-25
G018SN2501061Doctors ChoiceSN2501062021-03-25
G018SN2515061Doctors ChoiceSN2515062021-03-25
G018SYS01061Doctors ChoiceSYS01062021-03-25
G018SYS03061Doctors ChoiceSYS03062021-03-25
G018SYSR032515020Doctors ChoiceSYSR032515022021-02-03
G018SND23G01020Doctors ChoiceSND23G01022021-03-03

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