FDA.reportPublic FDA data

Gold Tai Chi™

Primary DI
16970514320486
Brand
Gold Tai Chi™
Company
Suzhou Shenlong Medical Apparatus Co., Ltd.
Model
AY8631
Catalog number
AY8631
Device description
High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture needles with spiral wound gold plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.18 x 25mm.
Published
2016-07-26
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

Contact Domains#

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
K023787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023787000TAI-CHI AND MASTER ACUPUNCTURE NEEDLESLhasa Medical, Inc.2003-02-14MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36970514320480PackageGS110In Commercial Distribution
16970514320486PrimaryGS10
06970514320489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697051432048036970514320480
1697051432048616970514320486
06970514320489069705143204896970514320489

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

Contacts#

Phone, Email table
PhoneEmail
800-722-8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
545745192
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14897076721778Roll.Smoke.LGY55102023-04-07
16970514320028Tai Chi™ Power 80AY7102AY710122016-07-22
16970514320035Tai Chi™ Power 80AY7103AY710132016-07-22
16970514320042Tai Chi™ Power 80AY7104AY710142016-07-22
16970514320059Tai Chi™ Power 80AY7105AY710152016-07-22
16970514320066Tai Chi™ Power 80AY7106AY710162016-07-22
16970514320073Tai Chi™ Power 80AY7107AY710172016-07-22
16970514320080Tai Chi™ Power 80AY7108AY710182016-07-22
16970514320097Tai Chi™ Power 80AY7109AY710192016-07-22
16970514320103Tai Chi™ Power 80AY7110AY71102016-07-22
16970514320110Tai Chi™ Power 80AY7111AY71112016-07-22
16970514320127Tai Chi™ SingleAY8423AY84232016-07-22
16970514320134Tai Chi™ SingleAY8101AY81012016-07-22
16970514320141Tai Chi™ SingleAY8102AY81022016-07-22
16970514320158Tai Chi™ SingleAY8103AY81032016-07-22
16970514320165Tai Chi™ SingleAY8424AY84242016-07-22
16970514320172Tai Chi™ SingleAY8106AY81062016-07-22
16970514320189Tai Chi™ SingleAY8107AY81072016-07-22
16970514320196Tai Chi™ SingleAY8108AY81082016-07-22
16970514320202Tai Chi™ SingleAY8109AY81092016-07-22

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