FDA.reportPublic FDA data

SEIRIN ACUPUNCTURE NEEDLE

Primary DI
14547248705012
Brand
SEIRIN ACUPUNCTURE NEEDLE
Company
SEIRIN CORPORATION
Model
J15 (J-Sakura15) No.03(0.10)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
14547248705012PackageGS110In Commercial Distribution
04547248705015PrimaryGS10
24547248705019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454724870501214547248705012
04547248705015045472487050154547248705015
2454724870501924547248705019

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 Diameter0.1Millimeter

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
04547248022105SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x15mm2026-02-11
04547248022167SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.2(0.18)x30mm2026-02-11
04547248420109SEIRIN PYONEX NEEDLESPyonex 0.20x1.7mm2026-02-11
14547248022102SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x15mm2026-02-11
14547248022164SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.2(0.18)x30mm2026-02-11
14547248420106SEIRIN PYONEX NEEDLESPyonex 0.20x1.7mm2026-02-11
04547248420017SEIRIN PYONEX NEEDLESPyonex Orange 0.11x0.3mm2017-08-22
04547248420024SEIRIN PYONEX NEEDLESPyonex Yellow 0.15x0.6mm2017-08-22
04547248420031SEIRIN PYONEX NEEDLESPyonex Green 0.17x0.9mm2017-08-22
04547248420048SEIRIN PYONEX NEEDLESPyonex Blue 0.20x1.2mm2016-04-01
04547248420062SEIRIN PYONEX NEEDLESPyonex Pink 0.20x1.5mm2016-04-01
04547248240264SEIRIN ACUPUNCTURE NEEDLEKB-Type No.3(0.20)X90mm2016-12-19
04547248240288SEIRIN ACUPUNCTURE NEEDLEKB-Type No.3(0.20)x150mm2016-12-19
04547248240431SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x75mm2016-12-19
04547248240448SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x90mm2016-12-19
04547248240455SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x120mm2016-12-19
04547248240462SEIRIN ACUPUNCTURE NEEDLEKB-Type No.5(0.25)x150mm2016-12-19
04547248240523SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x75mm2016-12-19
04547248240530SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x90mm2016-12-19
04547248240547SEIRIN ACUPUNCTURE NEEDLEKB-Type No.8(0.30)x120mm2016-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27