FDA.reportPublic FDA data

Shifeng

Primary DI
G002UU1SHN23100
Brand
Shifeng
Company
SHIFENG MEDICAL TECHNOLOGY CO.，LTD.
Model
UU1SHN2310
Published
2021-02-03
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132553000U&U STERILE PISTON SYRINGE WITHOUT NEEDLEU&U Medical Technology Co, Ltd.2014-02-27FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G002UU1SHN23100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554525197
Device count
1
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
G002100640EZ100642024-10-30
G002100620EZ100622024-10-28
G002HSB107119House Brand DentistryHSB-1071192023-09-25
G002HSB107110House brand HSB-1071102023-05-10
G002RG30RG3RG32022-07-22
G002100630Shifeng100632022-04-29
HSB107200House brandHSB-1072002022-04-17
HSB107114House brandHSB-1071142022-04-09
G002100170Shifeng100172021-09-26
G002100350Shifeng100352021-09-26
G002100360Shifeng100362021-09-26
G00210112251B0Shifeng1011-2251B2021-05-05
G002UU1L0UUUU1L2021-05-05
UUSF2251SN0ShifengUUSF2251SN2021-03-06
UUSF1LHN25100ShifengUUSF1LHN25102021-03-06
UUSF2231SN0ShifengUUSF2231SN2021-03-06
G002FUSF2510SN0FUTURE GENERATION MEDICALFUSF2510SN2021-02-27
G002UUSF1LHN23100ShifengUUSF1LHN23102021-02-27
G002UUSF2310SN0ShifengUUSF2310SN2021-02-27
G002UUSF1LL0ShifengUUSF1LL2021-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01