FDA.reportPublic FDA data

SEIRIN ACUPUNCTURE NEEDLE

Primary DI
14547248705043
Brand
SEIRIN ACUPUNCTURE NEEDLE
Company
SEIRIN CORPORATION
Model
J15 (J-Sakura15) No.02(0.12)x15mm
Device description
The J-15 is perfect for facial, auricular, hand acupuncture, or wherever shallow needling is performed. Available in the thinnest gauges you can find (03, 02, 01, and 1), this 15 mm needle comes with rounded guide tubes for accurate, gentle, painless and stress-free acupuncture. The J-15 also features ProPak™ technology, which allows you to open one or more blister packs quickly and easily. One surgical stainless steel needle per blister package. Features lightweight, color coded, 2.0 x 20 mm easy release comfort grip plastic handle with Light Touch Insertion. Sterile, disposable. Box of 100 needles.
Published
2024-04-18
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
14547248705043PackageGS110In Commercial Distribution
04547248705046PrimaryGS10
24547248705040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454724870504314547248705043
04547248705046045472487050464547248705046
2454724870504024547248705040

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
Length15Millimeter
Outer Diameter0.12Millimeter

Sterilization Methods#

Method table
Method

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
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