FDA.reportPublic FDA data

Myotech Six Series Dry Needles

Primary DI
09351885000205
Brand
Myotech Six Series Dry Needles
Company
RED CORAL ACUPUNCTURE SUPPLIES PTY LTD
Model
RCMsix3040
Device description
Myotech Dry Needles 6 Series 0.30x40mm
Published
2017-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K052731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052731000KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLESDaxin LI2006-02-01MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351885000205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351885000205093518850002059351885000205

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1300240656customerservice@redcoral.com.au

Regulatory Flags#

DUNS number
756950478
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351885000007Red Coral J-typeRCJ25302017-06-08
09351885000014Red Coral J-typeRCJ25402017-06-08
09351885000021Red Coral J-typeRCJ30302017-06-08
09351885000038Red Coral J-typeRCJ30402017-06-08
09351885000045Red Coral J-typeRCJ30502017-06-08
09351885000052Red Coral J-typeRCJ30602017-06-08
09351885000069Red Coral J-typeRCJ30752017-06-08
09351885000076Red Coral J-typeRCJ301002017-06-08
09351885000083Red Coral J-typeRCJ401002017-06-08
09351885000106Myotech Dry NeedlesRCM25302017-06-08
09351885000113Myotech Dry NeedlesRCM25402017-06-08
09351885000120Myotech Dry NeedlesRCM30302017-06-08
09351885000137Myotech Dry NeedlesRCM30402017-06-08
09351885000144Myotech Dry NeedlesRCM30502017-06-08
09351885000151Myotech Dry NeedlesRCM30602017-06-08
09351885000168Myotech Dry NeedlesRCM30752017-06-08
09351885000175Myotech Dry NeedlesRCM301002017-06-08
09351885000182Myotech Dry NeedlesRCM401002017-06-08
09351885000199Myotech Dry NeedlesRCM451352017-06-08
09351885000212Myotech Six Series Dry NeedlesRCMsix30502017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810202812642TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812666TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812680TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812703TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812727TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812741TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812765TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812789TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812802TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812826TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812840TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812864TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812888TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812901TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812925TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812956TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812970TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202812994TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813038TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813052TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813076TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813090TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813113TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01