FDA.reportPublic FDA data

STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE

Primary DI
06971685272829
Brand
STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
Company
Changchun AIK Medical Devices Co., Ltd.
Model
0.25*40
Device description
The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized by gamma-rays radiation. Ten needles per sterile, individually packed a pouch, 100 needles per box.
Published
2019-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K162566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162566000AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd.2017-05-11MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971685272829PrimaryGS10
16971685274134Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971685272829069716852728296971685272829
1697168527413416971685274134

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543439762
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
06977427144492BON Spring Needles0.22*15mm2026-03-19
06977427144508BON Spring Needles0.22*30mm2026-03-19
06977427144515BON Spring Needles0.22*40mm2026-03-19
26977427144496BON Spring Needles0.22*15mm2026-03-19
26977427144502BON Spring Needles0.22*30mm2026-03-19
26977427144519BON Spring Needles0.22*40mm2026-03-19
06977427142788BON Spring Needles0.16*15mm2025-07-15
06977427142795BON Spring Needles0.16*30mm2025-07-15
06977427142801BON Spring Needles0.18*15mm2025-07-15
06977427142818BON Spring Needles0.18*30mm2025-07-15
06977427142825BON Spring Needles0.20*15mm2025-07-15
06977427142832BON Spring Needles0.20*30mm2025-07-15
06977427142849BON Spring Needles0.20*40mm2025-07-15
06977427142856BON Spring Needles0.25*30mm2025-07-15
06977427142863BON Spring Needles0.25*40mm2025-07-15
06977427142870BON Spring Needles0.25*50mm2025-07-15
06977427142887BON Spring Needles0.25*60mm2025-07-15
06977427142894BON Spring Needles0.30*30mm2025-07-15
06977427142900BON Spring Needles0.30*40mm2025-07-15
06977427142917BON Spring Needles0.30*50mm2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00807689000457LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
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00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
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00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23