FDA.reportPublic FDA data

KM NEEDLE

Primary DI
18800020500035
Brand
KM NEEDLE
Company
K. M. S
Model
KMS GS0205020
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 length. All these components are disposable.
Published
2016-09-21
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
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
28800020500032PackageGS110In Commercial Distribution
38800020500039PackageGS110In Commercial Distribution
18800020500035PrimaryGS10
08800020500038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880002050003228800020500032
3880002050003938800020500039
1880002050003518800020500035
08800020500038088000205000388800020500038

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

Contacts#

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

Regulatory Flags#

DUNS number
689846211
Device count
100
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
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
08437016482285AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482292AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482308AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482315AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482322AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482339AGUPUNT IPENAGU PUNT SLMQX2022-04-27
08437016482407AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482414AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482421AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482438AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482445AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482452AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482469AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482476AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482483AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482490AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482506AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482513AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482520AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482537AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482551AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482568AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482575AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482582AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482599AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482605AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482612AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482629AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482636AGUPUNT APSAGU PUNT SLMQX2022-04-27
08437016482643AGUPUNT APSAGU PUNT SLMQX2022-04-27