FDA.reportPublic FDA data

SMC acupuncture needle

Primary DI
08800020300218
Brand
SMC acupuncture needle
Company
SMC
Model
02203025
Device description
SMC acupuncture needle 0.22*30 (1,000pcs/Box) 25mm HandleSMC's sterile, disposable, and surgical stainless steel acupuncture needles with style handle. Due to its automated manufactering procedure, the needle provides the consistancy in its quality.
Published
2016-10-13
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
K141473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141473000SMC ACUPUNCTURE NEEDLESmc Intl., Inc.2014-08-01MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800020300447PackageGS110In Commercial Distribution
08800020300874PackageGS110In Commercial Distribution
08800020300218PrimaryGS10
88800020300214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020300447088000203004478800020300447
08800020300874088000203008748800020300874
08800020300218088000203002188800020300218
8880002030021488800020300214

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
Device Size Text, specify0

Regulatory Flags#

DUNS number
689846232
Device count
1000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020300010SMC acupuncture needle016015202016-09-27
08800020300027SMC acupuncture needle018015202016-10-18
08800020300041SMC acupuncture needle020040252016-09-27
08800020300072SMC acupuncture needle025030252016-09-27
08800020300096SMC acupuncture needle030040252016-09-27
08800020300119SMC acupuncture needle030060252016-10-13
08800020300164SMC acupuncture needle020015202016-09-27
08800020300171SMC acupuncture needle016030252016-09-27
08800020300188SMC acupuncture needle018030252016-09-26
08800020300195SMC acupuncture needle018040252016-09-27
08800020300201SMC acupuncture needle020030252016-09-27
08800020300225SMC acupuncture needle022040252016-09-27
08800020300232SMC acupuncture needle025040252016-09-27
08800020300249SMC acupuncture needle025050252016-09-27
08800020300256SMC acupuncture needle025060252016-09-27
08800020300263SMC acupuncture needle016015202016-09-28
08800020300270SMC acupuncture needle016030252016-09-27
08800020300287SMC acupuncture needle018030252016-09-27
08800020300294SMC acupuncture needle018040252016-09-27
08800020300300SMC acupuncture needle020015202016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00807689000365LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000372LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000389LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000396LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000402LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000419LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000426LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000433LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000440LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000457LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000488LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000495LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000501LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000518LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000525LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000532LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000549LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000556LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000563LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000570LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000587LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000594LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23