FDA.reportPublic FDA data

Expert

Primary DI
00807689100423
Brand
Expert
Company
C A I INDUSTRIES CORP
Model
EP10-1830
Catalog number
NA-EP10-1830
Device description
0.18x30mm 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
00807689100423PrimaryGS10
00807689101420Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689100423008076891004238076891004230807689100423
00807689101420008076891014208076891014200807689101420

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1Inch
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
04547248024598SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-08-24
04547248024604SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-08-24
04547248021108SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248021153SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248021207SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248021382SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248022112SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248022211SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024055SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024062SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024086SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024093SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024116SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024123SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024130SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024161SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024178SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024185SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024215SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024222SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024239SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024246SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024307SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024314SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024321SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024390SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024406SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024413SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024420SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31
04547248024482SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-05-31