FDA.reportPublic FDA data

Tai Chi™ Single

Primary DI
36970514320237
Brand
Tai Chi™ Single
Company
Suzhou Shenlong Medical Apparatus Co., Ltd.
Model
AY8113
Catalog number
AY8113
Device description
Sterile, disposable, surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. One needle with one ins
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
36970514320237PackageGS110In Commercial Distribution
16970514320233PrimaryGS10
06970514320236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697051432023736970514320237
1697051432023316970514320233
06970514320236069705143202366970514320236

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

Contacts#

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

Regulatory Flags#

DUNS number
545745192
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
false
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
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