FDA.reportPublic FDA data

SHENMEN

Primary DI
B491SM1300501
Brand
SHENMEN
Company
Wujiang City ShenLing Medical Device Co.,Ltd
Model
SM130050
Catalog number
SM130050
Device description
"Smooth and sharp for painless, SHENMEN disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Sterilized with Ethylene Oxide. Each needle is individually sealed with guide tube. 0.30mm x 13mm (30# x 0.5"")."
Published
2017-12-22
Public version status
Update
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
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002411000SHENLING ACUPUNCTURE NEEDLESShenling Medical Device Co., Ltd.2000-12-12MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B491SM1300503PackageHIBCC100In Commercial Distribution
B491SM1300501PrimaryHIBCC0
B491SM1300500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
654613546
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
B491AZ112151AcuZoneAZ 1-1215AZ 1-12152017-12-21
B491AZ112301AcuZoneAZ 1-1230AZ 1-12302017-12-21
B491AZ112401AcuZoneAZ 1-1240AZ 1-12402017-12-21
B491AZ114151AcuZoneAZ 1-1415AZ 1-14152017-12-21
B491AZ114301AcuZoneAZ 1-1430AZ 1-14302017-12-21
B491AZ114401AcuZoneAZ 1-1440AZ 1-14402017-12-21
B491AZ116151AcuZoneAZ 1-1615AZ 1-16152017-12-21
B491AZ116301AcuZoneAZ 1-1630AZ 1-16302017-12-21
B491AZ116401AcuZoneAZ 1-1640AZ 1-16402017-12-21
B491AZ118151AcuZoneAZ 1-1815AZ 1-18152017-12-21
B491AZ118301AcuZoneAZ 1-1830AZ 1-18302017-12-21
B491AZ118401AcuZoneAZ 1-1840AZ 1-18402017-12-21
B491AZ118501AcuZoneAZ 1-1850AZ 1-18502017-12-21
B491AZ120151AcuZoneAZ 1-2015AZ 1-20152017-12-21
B491AZ120301AcuZoneAZ 1-2030AZ 1-20302017-12-21
B491AZ120401AcuZoneAZ 1-2040AZ 1-20402017-12-21
B491AZ120501AcuZoneAZ 1-2050AZ 1-20502017-12-21
B491AZ120601AcuZoneAZ 1-2060AZ 1-20602017-12-21
B491AZ12155AcuZoneAZ-1215AZ-12152017-12-21
B491AZ1221001AcuZoneAZ 1-22100AZ 1-221002017-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10