FDA.reportPublic FDA data

Balance

Primary DI
10854166000711
Brand
Balance
Company
BLUE POPPY ENTERPRISES INC.
Model
2230
Device description
Balance 1KS Type 2230
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K150903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150903000EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral NaturalMaanshan Bond Medical Instruments Co., Ltd.2015-07-15MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854166000711PrimaryGS10
00854166000233Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085416600071110854166000711
00854166000233008541660002338541660002330854166000233

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
Ethylene Oxide

Regulatory Flags#

DUNS number
080493003
Device count
1000
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854166000230Tempo L-Type Acupuncture NeedleTempo L-Type 16302019-01-14
10854166000001Tempo J-Type Acupuncture NeedleTempo J-Type 12152019-01-11
10854166000049Tempo J-Type Acupuncture NeedleTempo J-Type 16152019-01-11
10854166000056Tempo J-Type Acupuncture NeedleTempo J-Type 16302019-01-11
10854166000063Tempo J-Type Acupuncture NeedleTempo J-Type 16402019-01-11
10854166000087Tempo J-Type Acupuncture NeedleTempo J-Type 18402019-01-11
10854166000100Tempo J-Type Acupuncture NeedleTempo J-Type 20402019-01-11
10854166000117Tempo J-Type Acupuncture NeedleTempo J-Type 20502019-01-11
10854166000124Tempo J-Type Acupuncture NeedleTempo J-Type 22302019-01-11
10854166000131Tempo J-Type Acupuncture NeedleTempo J-Type 22402019-01-11
10854166000148Tempo J-Type Acupuncture NeedleTempo J-Type 25302019-01-11
10854166000155Tempo J-Type Acupuncture NeedleTempo J-Type 25402019-01-11
10854166000179Tempo J-Type Acupuncture NeedleTempo J-Type 30302019-01-11
10854166000186Tempo J-Type Acupuncture NeedleTempo J-Type 30402019-01-11
10854166000193Tempo J-Type Acupuncture NeedleTempo J-Type 30502019-01-11
10854166000209Tempo J-Type Acupuncture NeedleTempo J-Type 30602019-01-11
10854166000247Tempo L-Type Acupuncture NeedleTempo L-Type 18302019-01-11
10854166000254Tempo L-Type Acupuncture NeedleTempo L-Type 18402019-01-11
10854166000278Tempo L-Type Acupuncture NeedleTempo L-Type 20402019-01-11
10854166000308Tempo L-Type Acupuncture NeedleTempo L-Type 22402019-01-11

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