Identity
- Trade Name
- SEIRIN ACUPUNCTURE NEEDLE FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- J15 (J-Sakura) No.01(0.14)x15mm FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248705077 FDA UDI
- FDA Product Code
- MQX FDA UDI
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.14 Millimeter FDA UDILength — 15 Millimeter FDA UDI
Category: Acupuncture needle, single-use
Seirin Acupuncture Needle by Seirin Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture needle, single-use.
- Energy Flo Value-Pak J Type Acupuncture Needles — Acu Market · Class II
- ASIA MED — asia-med GmbH · Class II
- CARBO — WuJiang City Cloud&Dragon Medical Device Co., Ltd. · Class II
- STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE — Changchun AIK Medical Devices Co., Ltd. · Class II
- SHUNLI — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
- AcuZone — Wujiang City ShenLing Medical Device Co., Ltd · Class II
- ASIA MED — asia-med GmbH · Class II
- Millennia Bulk Acupuncture Needle — UPC MEDICAL SUPPLIES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Seirin Corporation
Sources (1)
- FDA UDI d8cb5253-1138-4b5d-9c66-debc5f5b055d 35 fields · synced Jun 1, 2026