FDA.reportPublic FDA data

TEWA

Primary DI
04251282514488
Brand
TEWA
Company
asia-med GmbH
Model
PJ-Type 2025
Catalog number
A012188
Device description
TeWa PJ-Type 2025: coated acupuncture needles with plastic handle|with guide tube|Packaging: 1 needle per blister|Size: Gauge 3(x 1.0") / 0.20 x 25 m
Published
2017-11-30
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132896000CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBEAsia-Med GmbH and CO KG2013-12-02MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251282514488PackageGS110In Commercial Distribution
04251282514471PrimaryGS10
04251282514464Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251282514488042512825144884251282514488
04251282514471042512825144714251282514471
04251282514464042512825144644251282514464

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
Length25Millimeter
Outer Diameter0.2Millimeter

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
04251282515447TEWAKJ-Type 3075A0125532023-03-23
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

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Primary DI, Brand, Company table
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