FDA.reportPublic FDA data

S NEEDLE

Primary DI
04251282505202
Brand
S NEEDLE
Company
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
Model
J-Type 2030 Place N' Press
Catalog number
A000684
Device description
"asia-med s-needle J-Type 2030 Place N' Press: coated acupuncture needles with plastic handle with Place N' Press guide tube Packaging: 1 needle per blister Size: Gauge 3(x 1.2"") / 0.20 x 30 mm Color code: light blue Sales unit: 100 pieces"
Published
2016-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04251282512200PackageGS110In Commercial Distribution
4251282505219PackageGS110Not in Commercial Distribution
04251282505202PreviousGS10
04251282512194PrimaryGS10
04251282505196Unit of UseGS10
04251282512187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251282512200042512825122004251282512200
4251282505219042512825052194251282505219
04251282505202042512825052024251282505202
04251282512194042512825121944251282512194
04251282505196042512825051964251282505196
04251282512187042512825121874251282512187

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
Length30Millimeter
Outer Diameter0.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius
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
Lot or batch
true
Expiration date on label
true

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

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