FDA.reportPublic FDA data

Balance

Primary DI
10854166000575
Brand
Balance
Company
BLUE POPPY ENTERPRISES INC.
Model
2275
Device description
Balance SL-Type 2275
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
10854166000575PrimaryGS10
00854166000233Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085416600057510854166000575
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
100
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
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