FDA.reportPublic FDA data

Alpha™ Acupuncture Needles

Primary DI
00818318024515
Brand
Alpha™ Acupuncture Needles
Company
Prime Holly Corporation
Model
N1 Type 0.22 x 15 mm
Catalog number
NAN1-3405
Device description
ALPHA™ acupuncture needles are precision engineered by professionals to provide a smooth, gentle, and stress free acupuncture treatment experience. Designed for reliable clinical performance and economical bulk use, each needle features a spring style metal handle for consistent insertion. Packaging includes 10 needles with 1 guide tube, 1000 needles per box.
Published
2022-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10818318024512PackageGS150In Commercial Distribution
00818318024515PrimaryGS10
20818318024519Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081831802451210818318024512
00818318024515008183180245158183180245150818318024515
2081831802451920818318024519

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
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
4085739889info@primeholly.com

Regulatory Flags#

DUNS number
080445043
Device count
1000
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
false
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
00818318024027Alpha™ Acupuncture NeedlesN1 Type 0.12 x 30 mmNAN1-44102026-09-10
00818318024126Alpha™ Acupuncture NeedlesN1 Type 0.14 x 30 mmNAN1-42102026-09-10
00818318024218Alpha™ Acupuncture NeedlesN1 Type 0.16 x 15 mmNAN1-40052022-01-24
00818318024225Alpha™ Acupuncture NeedlesN1 Type 0.16 x 30 mmNAN1-40102022-01-24
00818318024300Alpha™ Acupuncture NeedlesN1 Type 0.18 x 7 mmNAN1-38032022-01-24
00818318024317Alpha™ Acupuncture NeedlesN1 Type 0.18 x 15 mmNAN1-38052022-01-24
00818318024324Alpha™ Acupuncture NeedlesN1 Type 0.18 x 30 mmNAN1-38102022-01-24
00818318024331Alpha™ Acupuncture NeedlesN1 Type 0.18 x 40 mmNAN1-38152022-01-24
00818318024416Alpha™ Acupuncture NeedlesN1 Type 0.20 x 15 mmNAN1-36052022-01-24
00818318024423Alpha™ Acupuncture NeedlesN1 Type 0.20 x 30 mmNAN1-36102022-01-31
00818318024430Alpha™ Acupuncture NeedlesN1 Type 0.20 x 40 mmNAN1-36152022-01-24
00818318024522Alpha™ Acupuncture NeedlesN1 Type 0.22 x 30 mmNAN1-34102022-01-24
00818318024539Alpha™ Acupuncture NeedlesN1 Type 0.22 x 40 mmNAN1-34152022-01-24
00818318024546Alpha™ Acupuncture NeedlesN1 Type 0.22 x 50 mmNAN1-34202022-01-24
00818318024614Alpha™ Acupuncture NeedlesN1 Type 0.25 x 15 mmNAN1-32052022-01-24
00818318024621Alpha™ Acupuncture NeedlesN1 Type 0.25 x 30 mmNAN1-32102022-01-24
00818318024638Alpha™ Acupuncture NeedlesN1 Type 0.25 x 40 mmNAN1-32152022-01-24
00818318024720Alpha™ Acupuncture NeedlesN1 Type 0.30 x 30 mmNAN1-30102022-01-24
00818318024737Alpha™ Acupuncture NeedlesN1 Type 0.30 x 40 mmNAN1-30152022-01-24
00818318024751Alpha™ Acupuncture NeedlesN1 Type 0.30 x 60 mmNAN1-30252022-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810202813137TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813175TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01