FDA.reportPublic FDA data

TEWA

Primary DI
04251282515447
Brand
TEWA
Company
asia-med GmbH
Model
KJ-Type 3075
Catalog number
A012553
Device description
TeWa KJ-Type 3075: coated acupuncture needles with Korean style, non-looped steel coil handle|with guide tube|Packaging: 1 needle per blister|Size: Gauge 8(x 3.0") / 0.30 x 75 mm|Color code: yellow|Sales unit: 100 pieces
Published
2023-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
04251282515447PackageGS110In Commercial Distribution
04251282515430PrimaryGS10
04251282515423Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251282515447042512825154474251282515447
04251282515430042512825154304251282515430
04251282515423042512825154234251282515423

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
Length75Millimeter
Outer Diameter0.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49897473150info@asiamed.com

Regulatory Flags#

DUNS number
333450844
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
false
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
04251282515409TEWAKJ-Type 3050A0125522023-03-23
04251282515430TEWAKJ-Type 3075A0125532023-03-23
04251282515393TEWAKJ-Type 3050A0125522023-03-23
04251282507268ASIA MEDSpecial+ 3040A0007672017-11-30
04251282507299ASIA MEDSpecial+ 3050A0007672017-11-30
04251282507336ASIA MEDSpecial No. 11A0003472017-11-30
04251282507367ASIA MEDSpecial No. 12A0003482017-11-30
04251282507398ASIA MEDSpecial No. 13A0003492017-11-30
04251282507428ASIA MEDSpecial No. 14A0003502017-11-30
04251282507459ASIA MEDSpecial No. 15A0003512017-11-30
04251282507480ASIA MEDSpecial No. 16A0003522017-11-30
04251282507510ASIA MEDSpecial No. 17A0003532017-11-30
04251282507541ASIA MEDSpecial No. 19A0003542017-11-30
04251282507572ASIA MEDStandard No. 1A0003562017-11-30
04251282507602ASIA MEDStandard No. 2A0003572017-11-30
04251282507633ASIA MEDStandard No. 3A0003582017-11-30
04251282507664ASIA MEDStandard No. 4A0003592017-11-30
04251282507695ASIA MEDStandard No. 5A0003602017-11-30
04251282507725ASIA MEDStandard No. 6A0003612017-11-30
04251282507756ASIA MEDStandard No. 7A0003622017-11-30

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