FDA.reportPublic FDA data

AcuRight

Primary DI
04719674800569
Brand
AcuRight
Company
SUN TEN PHARMACEUTICAL CO., LTD.
Model
C-type 0.25*25mm
Device description
AcuRight Traditional Stainless Steel Wired Handle with Loop Acupuncture Needles with size 0.25*25mm. 500 Needles and 50 Guide tubes per box.
Published
2020-09-11
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
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719674800569PrimaryGS10
14719674800566Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719674800569047196748005694719674800569
1471967480056614719674800566

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid high temperature and humidity.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656338282
Device count
500
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719674800484AcuRightJ-type 0.16*30mm2020-09-11
04719674800491AcuRightJ-type 0.18*30mm2020-09-11
04719674800507AcuRightJ-type 0.18*40mm2020-09-11
04719674800514AcuRightJ-type 0.20*30mm2020-09-11
04719674800521AcuRightJ-type 0.20*40mm2020-09-11
04719674800538AcuRightJ-type 0.25*30mm2020-09-11
04719674800545AcuRightJ-type 0.25*40mm2020-09-11
04719674800552AcuRightJ-type 0.25*50mm2020-09-11
04719674800583AcuRightC-type 0.25*50mm2020-09-11
04719674800590AcuRightC-type 0.30*25mm2020-09-11
04719674800606AcuRightC-type 0.30*40mm2020-09-11
04719674800613AcuRightC-type 0.30*50mm2020-09-11
04719674800620AcuRightC-type 0.35*25mm2020-09-11
04719674800637AcuRightC-type 0.35*40mm2020-09-11
04719674800644AcuRightC-type 0.35*50mm2020-09-11
14719674800481AcuRightJ-type 0.16*30mm2020-09-11
14719674800498AcuRightJ-type 0.18*30mm2020-09-11
14719674800504AcuRightJ-type 0.18*40mm2020-09-11
14719674800511AcuRightJ-type 0.20*30mm2020-09-11
14719674800528AcuRightJ-type 0.20*40mm2020-09-11

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