FDA.reportPublic FDA data

STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE

Primary DI
06971685270108
Brand
STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
Company
Changchun AIK Medical Devices Co., Ltd.
Model
0.20*13
Device description
The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. One needle with one tube per sterile, individually blister package, 100 needles per box.
Published
2019-09-25
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
06971685270108PrimaryGS10
16971685272017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971685270108069716852701086971685270108
1697168527201716971685272017

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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00807689000495LEKONC A I INDUSTRIES CORPMQX2026-07-11
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00807689000587LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000594LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
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00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23