FDA.reportPublic FDA data

Expert

Primary DI
00807689100430
Brand
Expert
Company
C A I INDUSTRIES CORP
Model
EP10-1840
Catalog number
NA-EP10-1840
Device description
0.18x40mm acupuncture needles (10 needles with one tube per pack, 1000 per box).
Published
2017-04-03
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
K970574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970574000ACUPUNCTURE NEEDLESC.A.I. Industries Corp.1997-04-24MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00807689100430PrimaryGS10
00807689101437Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689100430008076891004308076891004300807689100430
00807689101437008076891014378076891014370807689101437

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
Length1.5Inch
Needle Gauge38Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859060303
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
00807689000365LEKONNA-LK05-12152026-07-11
00807689000372LEKONNA-LK05-12302026-07-11
00807689000389LEKONNA-LK05-14152026-07-11
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

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