FDA.reportPublic FDA data

Hansol Medical Co.

Primary DI
08809118710212
Brand
Hansol Medical Co.
Company
Hansol Medical Co.
Model
0.25mm 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
18809118710219PackageGS110In Commercial Distribution
08809118710212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880911871021918809118710219
08809118710212088091187102128809118710212

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
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
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01