FDA.reportPublic FDA data

Prime

Primary DI
00807689000099
Brand
Prime
Company
C A I INDUSTRIES CORP
Model
1615
Catalog number
NA-09-1615
Device description
0.16x15mm acupuncture needles (10 needles with 10 tubes per pack, 10 packs per box).
Published
2017-08-03
Public version status
Update
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
00807689000099PrimaryGS10
00807689000914Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00807689000099008076890000998076890000990807689000099
00807689000914008076890009148076890009140807689000914

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
Needle Gauge40Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859060303
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00807689003748LEKONNA-LK01-20502025-12-31
00807689003755LEKONNA-LK01-22152025-12-31
00807689003762LEKONNA-LK01-22302025-12-31
00807689003779LEKONNA-LK01-22402025-12-31
00807689003786LEKONNA-LK01-22502025-12-31
00807689003793LEKONNA-LK01-25152025-12-31
00807689003809LEKONNA-LK01-25302025-12-31
00807689003816LEKONNA-LK01-25402025-12-31
00807689003823LEKONNA-LK01-25502025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
26977427144496BON Spring NeedlesChangchun AIK Medical Devices Co., Ltd.MQX2026-03-19
26977427144502BON Spring NeedlesChangchun AIK Medical Devices Co., Ltd.MQX2026-03-19
26977427144519BON Spring NeedlesChangchun AIK Medical Devices Co., Ltd.MQX2026-03-19
14547248022102SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-02-11
14547248022164SEIRIN ACUPUNCTURE NEEDLESEIRIN CORPORATIONMQX2026-02-11
14547248420106SEIRIN PYONEX NEEDLESSEIRIN CORPORATIONMQX2026-02-11
B51710045901Energy Flo Value-Pak J Type Acupuncture NeedlesAcu MarketMQX2026-01-06
B51710050801Energy Flo Value-Pak J Type Acupuncture NeedlesAcu MarketMQX2026-01-06
B51710050901Energy Flo Value-Pak J Type Acupuncture NeedlesAcu MarketMQX2026-01-06
B51710051001Energy Flo Value-Pak J Type Acupuncture NeedlesAcu MarketMQX2026-01-06
B51710051201Energy Flo Value-Pak J Type Acupuncture NeedlesAcu MarketMQX2026-01-06
00807689101512LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003649LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003656LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003663LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003670LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003687LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003694LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003700LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003717LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003724LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003731LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003748LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003755LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003762LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003779LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003786LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003793LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003809LEKONC A I INDUSTRIES CORPMQX2025-12-31
00807689003816LEKONC A I INDUSTRIES CORPMQX2025-12-31