FDA.reportPublic FDA data

LEKON

Primary DI
00807689000389
Brand
LEKON
Company
C A I INDUSTRIES CORP
Model
NA-LK05-1415
Device description
acupuncture needles
Published
2026-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00807689000389PrimaryGS10
00807689101512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689000389008076890003898076890003890807689000389
00807689101512008076891015128076891015120807689101512

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.

Regulatory Flags#

DUNS number
859060303
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00807689000365LEKONNA-LK05-12152026-07-11
00807689000372LEKONNA-LK05-12302026-07-11
00807689000396LEKONNA-LK05-14302026-07-11
00807689000402LEKONNA-LK05-16152026-07-11
00807689000419LEKONNA-LK05-16302026-07-11
00807689000426LEKONNA-LK05-16402026-07-11
00807689000433LEKONNA-LK05-18152026-07-11
00807689000440LEKONNA-LK05-18302026-07-11
00807689000457LEKONNA-LK05-18402026-07-11
00807689000464LEKONNA-LK05-20152026-07-11
00807689000471LEKONNA-LK05-20302026-07-11
00807689000488LEKONNA-LK05-20402026-07-11
00807689000495LEKONNA-LK05-20502026-07-11
00807689000501LEKONNA-LK05-22152026-07-11
00807689000518LEKONNA-LK05-22302026-07-11
00807689000525LEKONNA-LK05-22402026-07-11
00807689000532LEKONNA-LK05-22502026-07-11
00807689000549LEKONNA-LK05-25152026-07-11
00807689000556LEKONNA-LK05-25302026-07-11
00807689000563LEKONNA-LK05-25402026-07-11

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
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
00816073023361HyChiHealth Body World Supply Inc.MQX2026-06-23