FDA.reportPublic FDA data

TEWA

Primary DI
04251282506629
Brand
TEWA
Company
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
Model
JJ-Type 1630
Catalog number
A000770
Device description
"TeWa JJ-Type 1630: coated acupuncture needles with Japanese style, smooth metal pipe handle with guide tube Packaging: 1 needle per blister Size: Gauge 1(x 1.2"") / 0.16 x 30 mm Color code: red Sales unit: 100 pieces"
Published
2016-08-30
Public version status
Update
Distribution status
Not 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
K132896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132896000CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBEAsia-Med GmbH and CO KG2013-12-02MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251282513641PackageGS110In Commercial Distribution
4251282506636PackageGS110Not in Commercial Distribution
04251282506629PreviousGS10
04251282513634PrimaryGS10
04251282506612Unit of UseGS10
04251282513627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251282513641042512825136414251282513641
4251282506636042512825066364251282506636
04251282506629042512825066294251282506629
04251282513634042512825136344251282513634
04251282506612042512825066124251282506612
04251282513627042512825136274251282513627

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
Length30Millimeter
Outer Diameter0.16Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature8 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49897473150info@asiamed.com

Regulatory Flags#

DUNS number
327997797
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251282500528TEWACB-Type 1625A0003662016-08-29
04251282501815TEWACB-Type 2030 (s)A0004192016-08-29
04251282501938TEWACB-Type 3020 (s)A0004232016-08-29
04251282502058TEWACB-Type 4020 (s)A0004272016-08-29
04251282502089TEWACB-Type 70100 (s)A0004282016-08-29
04251282502201TEWA5CB-Type 3025 Speed Pak (s)A0004332016-08-29
04251282502836TEWACJ-Type 4015A0004552016-08-29
04251282503284TEWACJ-Type 4015 (s)A0004712016-08-30
04251282506681TEWAJJ-Type 1840A0007722016-08-30
04251282507251TEWA10KB-Type 1808A0115502016-08-30
04251282500016ASIA MEDSpecial No. 11A0003472016-08-29
04251282500047ASIA MEDSpecial No. 12A0003482016-08-29
04251282500078ASIA MEDSpecial No. 13A0003492016-08-29
04251282500108ASIA MEDSpecial No. 14A0003502016-08-29
04251282500139ASIA MEDSpecial No. 15A0003512016-08-29
04251282500160ASIA MEDSpecial No. 16A0003522016-08-29
04251282500191ASIA MEDSpecial No. 17A0003532016-08-29
04251282500221ASIA MEDSpecial No. 19A0003542016-08-29
04251282500252ASIA MEDStandard No. 1A0003562016-08-29
04251282500283ASIA MEDStandard No. 2A0003572016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10