FDA.reportPublic FDA data

ASIA MED

Primary DI
04251282507312
Brand
ASIA MED
Company
asia-med GmbH
Model
Special+ 3050
Catalog number
A000767
Device description
asia-med Special+ 3050: coated acupuncture needles with rigid steel handle|with guide tube|Packaging: 1 needle per blister|Size: Gauge 8(x 2.0") / 0.
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
K031716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031716000SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPEAsia-Med GmbH and CO KG2003-07-10MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251282507312PackageGS110In Commercial Distribution
04251282507299PrimaryGS10
04251282507305Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251282507312042512825073124251282507312
04251282507299042512825072994251282507299
04251282507305042512825073054251282507305

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
Length50Millimeter
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
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00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
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00816073023385HyChiHealth Body World Supply Inc.MQX2026-06-23
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00816073023576SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
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00816073023743HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023750HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023767HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073024221SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024344SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024351SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024481SILVERSTARHealth Body World Supply Inc.MQX2026-06-23