FDA.reportPublic FDA data

Expert

Primary DI
00807689100522
Brand
Expert
Company
C A I INDUSTRIES CORP
Model
EP10-2030
Catalog number
NA-EP10-2030
Device description
0.20x30mm 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
00807689100522PrimaryGS10
00807689101529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689100522008076891005228076891005220807689100522
00807689101529008076891015298076891015290807689101529

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
Length1Inch
Needle Gauge36Gauge

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
00807689003618LEKONNA-LK01-12152025-12-31
00807689003625LEKONNA-LK01-12302025-12-31
00807689003632LEKONNA-LK01-14152025-12-31
00807689003915LEKONNA-LK01-12072025-12-31
00807689003922LEKONNA-LK01-14072025-12-31
00807689003939LEKONNA-LK01-16072025-12-31
00807689003953LEKONNA-LK01-20072025-12-31
00807689003960LEKONNA-LK01-22072025-12-31
00807689003977LEKONNA-LK01-25072025-12-31
00807689101512LEKONNA-LK01-14152025-12-31
00807689003649LEKONNA-LK01-14302025-12-31
00807689003656LEKONNA-LK01-16152025-12-31
00807689003663LEKONNA-LK01-16302025-12-31
00807689003670LEKONNA-LK01-16402025-12-31
00807689003687LEKONNA-LK01-18152025-12-31
00807689003694LEKONNA-LK01-18302025-12-31
00807689003700LEKONNA-LK01-18402025-12-31
00807689003717LEKONNA-LK01-20152025-12-31
00807689003724LEKONNA-LK01-20302025-12-31
00807689003731LEKONNA-LK01-20402025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10