FDA.reportPublic FDA data

Haeng Lim Acupuncture Needles

Primary DI
08809266934607
Brand
Haeng Lim Acupuncture Needles
Company
Heng Lim Seowon Medical
Model
HL-0011630A
Device description
Haeng Lim Spring Handle acupuncture needle,0.16mm-30mm,Outer package
Published
2017-02-08
Public version status
Update
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
K092240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092240000ACUPUNCTURE NEEDLESHaenglim Seowon Medical Co.2010-04-21MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809266934607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809266934607088092669346078809266934607

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.

Regulatory Flags#

DUNS number
631169893
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
08809266938674Haeng Lim Acupuncture NeedlesHL-0011607A2018-07-09
08809266930036Haeng Lim Acupuncture NeedlesHL-0011607A2018-03-26
08809266930067Haeng Lim Acupuncture NeedlesHL-0011615A2017-11-24
08809266930159Haeng Lim Acupuncture NeedlesHL-0011630A2017-02-08
08809266930456Haeng Lim Acupuncture NeedlesHL-0011830A2017-02-08
08809266930753Haeng Lim Acupuncture NeedlesHL-0012030A2017-02-08
08809266930814Haeng Lim Acupuncture NeedlesHL-0012040A2017-02-08
08809266930876Haeng Lim Acupuncture NeedlesHL-0012050A2017-02-08
08809266931354Haeng Lim Acupuncture NeedlesHL-0012530A2017-02-08
08809266931415Haeng Lim Acupuncture NeedlesHL-0012540A2017-02-08
08809266933969Haeng Lim Acupuncture NeedlesHL-0012575C2017-02-08
08809266933976Haeng Lim Acupuncture NeedlesHL-0012590C2017-11-20
08809266933983Haeng Lim Acupuncture NeedlesHL-00125105C2018-03-26
08809266933990Haeng Lim Acupuncture NeedlesHL-00125120C2018-04-09
08809266934010Haeng Lim Acupuncture NeedlesHL-0013075C2017-07-17
08809266934027Haeng Lim Acupuncture NeedlesHL-0013090C2017-07-17
08809266934034Haeng Lim Acupuncture NeedlesHL-00130105C2017-02-08
08809266934041Haeng Lim Acupuncture NeedlesHL-00130120C2017-02-08
08809266934065Haeng Lim Acupuncture NeedlesHL-0013575C2017-07-17
08809266934072Haeng Lim Acupuncture NeedlesHL-0013590C2017-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816073022500HBW PINEHealth Body World Supply Inc.MQX2020-10-19
00816073022630HBW UNISHARPHealth Body World Supply Inc.MQX2019-07-12
00816073020797HBW SILVERSTARHealth Body World Supply Inc.MQX2019-06-26
00816073022616HBW PINEHealth Body World Supply Inc.MQX2019-04-15
00816073022470HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022524HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022531HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022548HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022555HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022562HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022579HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022586HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022609HBW UNISHARPHealth Body World Supply Inc.MQX2019-03-08
00816073022395SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022401SILVERSTARHealth Body World Supply Inc.MQX2018-04-14
00816073022166HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022319HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022326HBW HI.CHIHealth Body World Supply Inc.MQX2017-08-06
00816073022333HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022340HBW SILVERSTARHealth Body World Supply Inc.MQX2017-08-06
00816073022036HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022050HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022067HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022074HBW 7 STAR NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022098HBW DETOX NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022296HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022302HBW INTRADERMAL NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073022043HBW PRESS NEEDLESHealth Body World Supply Inc.MQX2016-09-27
00816073021244HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10
00816073021251HBW E FIVEHealth Body World Supply Inc.MQX2016-09-10