FDA.reportPublic FDA data

KM NEEDLE

Primary DI
38800020500114
Brand
KM NEEDLE
Company
K. M. S
Model
KMS GS0305020
Device description
KM Needle general and hand type is general type its hair-thin shape of stainless steel wire. It has 0.16 ~ 0.70mm body diameter and 15 ~ 135mm body le
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K142920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142920000KM Needles (Acupuncture Needle)K.M.S., Inc.2015-06-10MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800020500117PackageGS110In Commercial Distribution
38800020500114PackageGS110In Commercial Distribution
18800020500110PrimaryGS10
08800020500113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880002050011728800020500117
3880002050011438800020500114
1880002050011018800020500110
08800020500113088000205001138800020500113

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82415587785kms93444@naver.com

Regulatory Flags#

DUNS number
689846211
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18800020500936KM NEEDLEKMS BE0356020102019-07-23
18800020500943KM NEEDLEKMS BE0203020202019-07-23
18800020500950KM NEEDLEKMS BE0204020202019-07-23
18800020500967KM NEEDLEKMS BE0253020202019-07-23
18800020500974KM NEEDLEKMS BE0254020202019-07-23
18800020500981KM NEEDLEKMS BE0303020202019-07-23
18800020500998KM NEEDLEKMS BE0304020202019-07-23
18800020500844KM NEEDLEKMS BE0256020102019-07-22
18800020500851KM NEEDLEKMS BE0301520102019-07-22
18800020500868KM NEEDLEKMS BE0303020102019-07-22
18800020500875KM NEEDLEKMS BE0304020102019-07-22
18800020500882KM NEEDLEKMS BE0355020102019-07-22
18800020500899KM NEEDLEKMS BE0306020102019-07-22
18800020500905KM NEEDLEKMS BE0353020102019-07-22
18800020500912KM NEEDLEKMS BE0354020102019-07-22
18800020500929KM NEEDLEKMS BE0355020102019-07-22
18800020500462KM NEEDLEKMS BE016152012019-07-21
18800020500479KM NEEDLEKMS BE016302012019-07-21
18800020500486KM NEEDLEKMS BE016402012019-07-21
18800020500493KM NEEDLEKMS BE018152012019-07-21

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