FDA.reportPublic FDA data

SEIRIN PYONEX NEEDLES

Primary DI
04547248435080
Brand
SEIRIN PYONEX NEEDLES
Company
SEIRIN CORPORATION
Model
PYONEX 1.7mm
Device description
Designed with both the patient and practitioner in mind, the new and advanced Pyonex continue SEIRIN's tradition of gentle, painless and stress free press needles. The patented plastic case and sheath allow the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic latex-free adhesive allows the skin to breathe during treatment. With SEIRIN's consistently smooth insertion, the result is a pleasant and painless experience for your patient.
Published
2026-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
14547248435087PackageGS110In Commercial Distribution
04547248420109PreviousGS10
04547248435080PrimaryGS10
24547248435084Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454724843508714547248435087
04547248420109045472484201094547248420109
04547248435080045472484350804547248435080
2454724843508424547248435084

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
Length0
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
800 722 8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
693307373
Device count
100
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
04547248021108SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.1(0.16)x15mm2026-05-31
04547248021153SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.2(0.18)x15mm2026-05-31
04547248021207SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.3(0.20)x15mm2026-05-31
04547248021382SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.5(0.25)x15mm2026-05-31
04547248022112SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x30mm2026-05-31
04547248022211SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.3(0.20)x30mm2026-05-31
04547248024055SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.02(0.12)x30mm2026-05-31
04547248024062SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.02(0.12)x40mm2026-05-31
04547248024086SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.01(0.14)x30mm2026-05-31
04547248024093SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.01(0.14)x40mm2026-05-31
04547248024116SEIRIN ACUPUNCTURE NEEDLEJ-type(JSP type) No.1(0.16)x30mm2026-05-31
04547248024123SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.1(0.16)x40mm2026-05-31
04547248024130SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.1(0.16)x50mm2026-05-31
04547248024161SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x30mm2026-05-31
04547248024178SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x40mm2026-05-31
04547248024185SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x50mm2026-05-31
04547248024215SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x30mm2026-05-31
04547248024222SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x40mm2026-05-31
04547248024239SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x50mm2026-05-31
04547248024246SEIRIN ACUPUNCTURE NEEDLEJ-type(JSP type) No.3(0.20)x60mm2026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768627017503Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00768627017510Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00768627017527Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00768627017534Red RubyNORTH COAST MEDICAL, INC.MQX2026-10-01
00818318024027Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
00818318024126Alpha™ Acupuncture NeedlesPrime Holly CorporationMQX2026-09-10
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