FDA.reportPublic FDA data

AcuZone

Primary DI
B491AZ116401
Brand
AcuZone
Company
Wujiang City ShenLing Medical Device Co.,Ltd
Model
AZ 1-1640
Catalog number
AZ 1-1640
Device description
"Smooth and sharp for painless, AcuZone disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Steriliized with Ethylene Oxide, each needle is individually sealed with a guide tube. Box of 100 needles. 0.16mm x 40mm (40# x 1.5"")."
Published
2017-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002411000SHENLING ACUPUNCTURE NEEDLESShenling Medical Device Co., Ltd.2000-12-12MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B491AZ116403PackageHIBCC100In Commercial Distribution
B491AZ116401PrimaryHIBCC0
B491AZ116400Unit of UseHIBCC0

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

Regulatory Flags#

DUNS number
654613546
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B491AZ112151AcuZoneAZ 1-1215AZ 1-12152017-12-21
B491AZ112301AcuZoneAZ 1-1230AZ 1-12302017-12-21
B491AZ112401AcuZoneAZ 1-1240AZ 1-12402017-12-21
B491AZ114151AcuZoneAZ 1-1415AZ 1-14152017-12-21
B491AZ114301AcuZoneAZ 1-1430AZ 1-14302017-12-21
B491AZ114401AcuZoneAZ 1-1440AZ 1-14402017-12-21
B491AZ116151AcuZoneAZ 1-1615AZ 1-16152017-12-21
B491AZ116301AcuZoneAZ 1-1630AZ 1-16302017-12-21
B491AZ118151AcuZoneAZ 1-1815AZ 1-18152017-12-21
B491AZ118301AcuZoneAZ 1-1830AZ 1-18302017-12-21
B491AZ118401AcuZoneAZ 1-1840AZ 1-18402017-12-21
B491AZ118501AcuZoneAZ 1-1850AZ 1-18502017-12-21
B491AZ120151AcuZoneAZ 1-2015AZ 1-20152017-12-21
B491AZ120301AcuZoneAZ 1-2030AZ 1-20302017-12-21
B491AZ120401AcuZoneAZ 1-2040AZ 1-20402017-12-21
B491AZ120501AcuZoneAZ 1-2050AZ 1-20502017-12-21
B491AZ120601AcuZoneAZ 1-2060AZ 1-20602017-12-21
B491AZ12155AcuZoneAZ-1215AZ-12152017-12-21
B491AZ1221001AcuZoneAZ 1-22100AZ 1-221002017-12-21
B491AZ1221251AcuZoneAZ 1-22125AZ 1-221252017-12-21

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