FDA.reportPublic FDA data

Hansol Medical Co.

Primary DI
08809118710571
Brand
Hansol Medical Co.
Company
Hansol Medical Co.
Model
0.35mm x 15mm
Published
2019-02-11
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
K090910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090910000HANSO ACUPUNCTURE NEEDLEHansol Medical Co.2009-06-30MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809118710578PackageGS110In Commercial Distribution
08809118710571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880911871057818809118710578
08809118710571088091187105718809118710571

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
557793906
Device count
1
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
08809118710151Hansol Medical Co.0.20mm x 90mm2019-02-11
08809118710175Hansol Medical Co.0.20mm x 105mm2019-02-11
08809118710199Hansol Medical Co.0.20mm x 120mm2019-02-11
08809118710311Hansol Medical Co.0.25mm x 75mm2019-02-11
08809118710335Hansol Medical Co.0.25mm x 90mm2019-02-11
08809118710359Hansol Medical Co.0.25mm x 105mm2019-02-11
08809118710373Hansol Medical Co.0.25mm x 120mm2019-02-11
08809118710496Hansol Medical Co.0.30mm x 75mm2019-02-11
08809118710519Hansol Medical Co.0.30mm x 90mm2019-02-11
08809118710533Hansol Medical Co.0.30mm x 105mm2019-02-11
08809118710557Hansol Medical Co.0.30mm x 120mm2019-02-11
08809118710670Hansol Medical Co.0.35mm x 75mm2019-02-11
08809118710694Hansol Medical Co.0.35mm x 90mm2019-02-11
08809118710717Hansol Medical Co.0.35mm x 105mm2019-02-11
08809118710731Hansol Medical Co.0.35mm x 120mm2019-02-11
08809118710854Hansol Medical Co.0.40mm x 75mm2019-02-11
08809118710878Hansol Medical Co.0.40mm x 90mm2019-02-11
08809118710892Hansol Medical Co.0.40mm x 105mm2019-02-11
08809118710915Hansol Medical Co.0.40mm x 120mm2019-02-11
08809118710953Hansol Medical Co.0.20mm x 75mm2019-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00807689000365LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000372LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000389LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000396LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000402LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000419LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000426LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000433LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000440LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000457LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000464LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000471LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000488LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000495LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000501LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000518LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000525LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000532LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000549LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000556LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000563LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000570LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000587LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000594LEKONC A I INDUSTRIES CORPMQX2026-07-11
00807689000600LEKONC A I INDUSTRIES CORPMQX2026-07-11
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23