FDA.reportPublic FDA data

Balance 1KS Acupuncture Needle

Primary DI
10854166000643
Brand
Balance 1KS Acupuncture Needle
Company
BLUE POPPY ENTERPRISES INC.
Model
Balance 1KS-Type 1815
Device description
Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS is an achievement in combining the highest quality with unprecedented value.
Published
2019-01-09
Public version status
New
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
10854166000643PrimaryGS10
30854166000647Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085416600064310854166000643
3085416600064730854166000647

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
Length15Millimeter
Outer Diameter0.18Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080493003
Device count
1000
Lot or batch
true
Serial number
true
Expiration date on label
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

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Primary DI, Brand, Company table
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00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
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