FDA.reportPublic FDA data

HWATO Yuezhen

Primary DI
16901452600811
Brand
HWATO Yuezhen
Company
Suzhou Medical Appliance Factory
Model
0.22 x 75
Device description
HWATO Yuezhen acupuncture needles, sterile, disposable, and surgical stainless steel Acupuncture Needles with spring style stainless steel handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100 needles.
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K974122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974122000ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIAScientific Health Care1998-01-22MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36901452600815PackageGS1100In Commercial Distribution
16901452600811PrimaryGS10
06901452600814Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3690145260081536901452600815
1690145260081116901452600811
06901452600814069014526008146901452600814

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
653739474
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
16901452970099Hua-Xia Basic Acupuncture Needles0.22x40Xb.22x402016-09-15
16901452900010Hwa-To Singles Acupuncture Needles0.20x13Hs.20x132016-09-15
06901452000003HWATO TDP Heat LampTDP11-DL 2017-04-05
16901452648196HWATO Yuezhen - ACA COMFORT NEEDLE0.16X132025-05-08
06901452648199HWATO Yuezhen - ACA COMFORT NEEDLE0.16X132025-05-08
06901452000010HWATO TDP Heat Lamp TDP12-XL2017-04-05
06901452000058HWATO TDP Heat LampTDP22-XL2017-04-05
16901452600330HWATO Yuezhen0.20 x 252017-01-26
16901452600569HWATO Yuezhen0.22 x 402017-01-26
16901452648073HWATO Yuezhen - ACA COMFORT NEEDLE0.25X252017-05-18
16901452648080HWATO Yuezhen - ACA COMFORT NEEDLE0.30X252017-05-18
16901452648097HWATO Yuezhen - ACA COMFORT NEEDLE0.20X402017-05-18
16901452648103HWATO Yuezhen - ACA COMFORT NEEDLE0.22X402017-05-18
16901452648110HWATO Yuezhen - ACA COMFORT NEEDLE0.25X402017-05-18
16901452648127HWATO Yuezhen - ACA COMFORT NEEDLE0.30X402017-05-18
16901452648134HWATO Yuezhen - ACA COMFORT NEEDLE0.20X502017-05-18
16901452648141HWATO Yuezhen - ACA COMFORT NEEDLE0.22X502017-05-18
16901452648158HWATO Yuezhen - ACA COMFORT NEEDLE0.25X502017-05-18
16901452648165HWATO Yuezhen - ACA COMFORT NEEDLE0.30X502017-05-18
16901452648172HWATO Yuezhen - ACA COMFORT NEEDLE0.25X132019-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27