FDA.reportPublic FDA data

AcuRight

Primary DI
04719674800583
Brand
AcuRight
Company
SUN TEN PHARMACEUTICAL CO., LTD.
Model
C-type 0.25*50mm
Device description
AcuRight Traditional Stainless Steel Wired Handle with Loop Acupuncture Needles with size 0.25*50mm. 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
04719674800583PrimaryGS10
14719674800580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719674800583047196748005834719674800583
1471967480058014719674800580

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

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
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
14719674800535AcuRightJ-type 0.25*30mm2020-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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