FDA.reportPublic FDA data

KM NEEDLE

Primary DI
18800020500974
Brand
KM NEEDLE
Company
K. M. S
Model
KMS BE025402020
Published
2019-07-23
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800020500971PackageGS110000In Commercial Distribution
38800020500978PackageGS1100000In Commercial Distribution
18800020500974PrimaryGS10
08800020500977Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880002050097128800020500971
3880002050097838800020500978
1880002050097418800020500974
08800020500977088000205009778800020500977

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
689846211
Device count
1000
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
18800020500509KM NEEDLEKMS BE018302012019-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810202813014TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202813151TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
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00810202813199TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813212TCMzone HuaTuoTCMZone, LLCMQX2026-08-01
00810202813236TCMzone HuaTuoTCMZone, LLCMQX2026-08-01