FDA.reportPublic FDA data

ASIA MED

Primary DI
04251282507282
Brand
ASIA MED
Company
asia-med GmbH
Model
Special+ 3040
Catalog number
A000767
Device description
asia-med Special+ 3040: coated acupuncture needles with rigid steel handle|with guide tube|Packaging: 1 needle per blister|Size: Gauge 8(x 1.5") / 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
04251282507282PackageGS110In Commercial Distribution
04251282507268PrimaryGS10
04251282507275Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251282507282042512825072824251282507282
04251282507268042512825072684251282507268
04251282507275042512825072754251282507275

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
Length40Millimeter
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
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