FDA.reportPublic FDA data

AcuZone

Primary DI
B491AZ120151
Brand
AcuZone
Company
Wujiang City ShenLing Medical Device Co.,Ltd
Model
AZ 1-2015
Catalog number
AZ 1-2015
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. 0.20mm x 15mm (36# x 0.5"")."
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
B491AZ120153PackageHIBCC100In Commercial Distribution
B491AZ120151PrimaryHIBCC0
B491AZ120150Unit 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
B491AZ116401AcuZoneAZ 1-1640AZ 1-16402017-12-21
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
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
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
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00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
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00816073023385HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023392HyChiHealth Body World Supply Inc.MQX2026-06-23
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00816073023415HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023422HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023576SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023583SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023644HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023651HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023675HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023682HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023699HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023705HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023712HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023729HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023736HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023743HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023750HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023767HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073024221SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024344SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024351SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024481SILVERSTARHealth Body World Supply Inc.MQX2026-06-23