FDA.reportPublic FDA data

ASIA MED

Primary DI
4251282500290
Brand
ASIA MED
Company
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
Model
Standard No. 2
Catalog number
A000357
Device description
asia-med Standard No. 2: uncoated acupuncture needles with copper-wire handle|without guide tube|Packaging: 1 needle per blister|Size: Gauge 3(x 0.6"
Published
2016-08-29
Public version status
Update
Distribution status
Not 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
K011808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011808000ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)Asia-Med GmbH and CO KG2001-07-10MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4251282500290PackageGS110Not in Commercial Distribution
04251282500283PrimaryGS10
04251282500276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4251282500290042512825002904251282500290
04251282500283042512825002834251282500283
04251282500276042512825002764251282500276

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
Length15Millimeter
Outer Diameter0.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
327997797
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
04251282500528TEWACB-Type 1625A0003662016-08-29
04251282501815TEWACB-Type 2030 (s)A0004192016-08-29
04251282501938TEWACB-Type 3020 (s)A0004232016-08-29
04251282502058TEWACB-Type 4020 (s)A0004272016-08-29
04251282502089TEWACB-Type 70100 (s)A0004282016-08-29
04251282502201TEWA5CB-Type 3025 Speed Pak (s)A0004332016-08-29
04251282502836TEWACJ-Type 4015A0004552016-08-29
04251282503284TEWACJ-Type 4015 (s)A0004712016-08-30
04251282506681TEWAJJ-Type 1840A0007722016-08-30
04251282507251TEWA10KB-Type 1808A0115502016-08-30
04251282500016ASIA MEDSpecial No. 11A0003472016-08-29
04251282500047ASIA MEDSpecial No. 12A0003482016-08-29
04251282500078ASIA MEDSpecial No. 13A0003492016-08-29
04251282500108ASIA MEDSpecial No. 14A0003502016-08-29
04251282500139ASIA MEDSpecial No. 15A0003512016-08-29
04251282500160ASIA MEDSpecial No. 16A0003522016-08-29
04251282500191ASIA MEDSpecial No. 17A0003532016-08-29
04251282500221ASIA MEDSpecial No. 19A0003542016-08-29
04251282500252ASIA MEDStandard No. 1A0003562016-08-29
04251282500283ASIA MEDStandard No. 2A0003572016-08-29

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