FDA.reportPublic FDA data

SHENMEN

Primary DI
B491SM1321503
Brand
SHENMEN
Company
Wujiang City ShenLing Medical Device Co.,Ltd
Model
SM132150
Catalog number
SM132150
Device description
Smooth and sharp for painless, SHENMEN disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is with
Published
2018-01-02
Public version status
Update
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
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
B491SM1321503PackageHIBCC100In Commercial Distribution
B491SM1321501PrimaryHIBCC0
B491SM1321500Unit 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654613546
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
false
No natural rubber latex
false
Sterilization required before use
false

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
00818318024027Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00818318024126Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813038TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813052TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813076TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813090TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01