FDA.report

SEIRIN SPINEX NEEDLE

Primary DI
14547248500013
Brand
SEIRIN SPINEX NEEDLE
Company
SEIRIN CORPORATION
Model
NS No.02(0.12)x3mm
Device description
An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality opt
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications

CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14547248500013PackageGS110In Commercial Distribution
04547248500016PrimaryGS10
24547248500010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1454724850001314547248500013
04547248500016045472485000164547248500016
2454724850001024547248500010

GMDN Terms

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

TypeValueUnit
Length3Millimeter
Outer Diameter0.12Millimeter

Sterilization Methods

Method

Contacts

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

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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
14547248244634SEIRIN ACUPUNCTURE NEEDLEKB-Type No.10(0.35)x120mm2025-07-31
14547248244641SEIRIN ACUPUNCTURE NEEDLEKB-Type No.10(0.35)x150mm2025-07-31
14547248423053SEIRIN PY-ZeroPY-Zero 0.3mm2025-03-03
24547248423067SEIRIN PY-ZeroPY-Zero 0.3mm Ø92025-03-03
14547248176102SEIRIN ACUPUNCTURE NEEDLED-Type (D-Kaede) No.1(0.16)x15mm2024-04-18
14547248176157SEIRIN ACUPUNCTURE NEEDLED-Type (D-Kaede) No.2(0.18)x15mm2024-04-18
14547248176201SEIRIN ACUPUNCTURE NEEDLED-Type (D-Kaede) No.3(0.20)x15mm2024-04-18
14547248176386SEIRIN ACUPUNCTURE NEEDLED-Type (D-Kaede) No.5(0.25)x15mm2024-04-18
24547248700120SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.1(0.16)x40mm2024-04-18
14547248700130SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.1(0.16)x50mm2024-04-18
14547248700161SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.2(0.18)x30mm2024-04-18
14547248700178SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.2(0.18)x40mm2024-04-18
24547248700182SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.2(0.18)x50mm2024-04-18
14547248700215SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.3(0.20)x30mm2024-04-18
14547248700222SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.3(0.20)x40mm2024-04-18
14547248700239SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.3(0.20)x50mm2024-04-18
14547248700314SEIRIN ACUPUNCTURE NEEDLEJ-Type (J-Sakura) No.4(0.23)x40mm2024-04-18

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