ASIA MED A000348

GUDID 04251282500047

asia-med Special No. 12: coated acupuncture needles with copper-wire handle|without guide tube|Packaging: 1 needle per blister|Size: Gauge 3(x 0.6")

asia-med GmbH

Acupuncture needle, single-use

• Primary Device ID: 04251282500047
• NIH Device Record Key: a581aa55-4ad8-48e4-ac13-fd79b4aa325d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASIA MED
• Version Model Number: Special No. 12
• Catalog Number: A000348
• Company DUNS: 333450844
• Company Name: asia-med GmbH
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com
• Phone: +49897473150
• Email: info@asiamed.com

Device Dimensions

• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 0.2 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251282500047 [Previous]
GS1	04251282507350 [Unit of Use]
GS1	04251282507367 [Primary]
GS1	04251282507374 [Package]; Contains: 04251282507367; Package: parcel [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011808

FDA Product Code

• MQX: Needle, Acupuncture, Single Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-30

On-Brand Devices [ASIA MED]

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• 04251282506537: asia-med Special+ No. 17: coated acupuncture needles with rigid steel handle|with guide tube|Pa
• 04251282506506: asia-med Special+2030: coated acupuncture needles with rigid steel handle|with guide tube|Packa
• 04251282506469: asia-med Special+ No. 12: coated acupuncture needles with rigid steel handle|with guide tube|Pa
• 04251282504274: asia-med Apex Steel: uncoated semi-permanent acupuncture needles with applicator and magnet.|Inc
• 04251282504243: asia-med PTN - large: uncoated semi-permanent acupuncture Press Tack Needle (PTN)|Packaging: 10
• 04251282504212: asia-med PTN - medium: uncoated semi-permanent acupuncture Press Tack Needle (PTN)|Packaging: 10
• 04251282504182: asia-med PTN - small: uncoated semi-permanent acupuncture Press Tack Needle (PTN)|Packaging: 10
• 04251282509538: asia-med Kinesiology Tape - Pink: made of cotton fabric with a medical grade acrylic adhesive a
• 04251282509521: asia-med Kinesiology Tape - Blue: made of cotton fabric with a medical grade acrylic adhesive a
• 04251282509378: asia-med Kinesiology Tape - Royal Blue: made of cotton fabric with a medical grade acrylic adhe
• 04251282509361: asia-med Kinesiology Tape - Dark Blue: made of cotton fabric with a medical grade acrylic adhes
• 04251282509255: asia-med Kinesiology Tape - Orange: made of cotton fabric with a medical grade acrylic adhesive
• 04251282509248: asia-med Kinesiology Tape - Tan color: made of cotton fabric with a medical grade acrylic adhes
• 04251282509149: asia-med Kinesiology Tape - BLUE: made of cotton fabric with a medical grade acrylic adhesive a
• 04251282509132: asia-med Kinesiology Tape - TAN: made of cotton fabric with a medical grade acrylic adhesive ap
• 04251282509125: asia-med Kinesiology Tape - Light Green: made of cotton fabric with a medical grade acrylic adh
• 04251282500467: asia-med Standard No. 9: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500436: asia-med Standard No. 7: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500405: asia-med Standard No. 6: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500375: asia-med Standard No. 5: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500344: asia-med Standard No. 4: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500313: asia-med Standard No. 3: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500283: asia-med Standard No. 2: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500252: asia-med Standard No. 1: uncoated acupuncture needles with copper-wire handle|without guide tub
• 04251282500221: asia-med Special No. 19: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500191: asia-med Special No. 17: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500160: asia-med Special No. 16: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500139: asia-med Special No. 15: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500108: asia-med Special No. 14: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500078: asia-med Special No. 13: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500047: asia-med Special No. 12: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282500016: asia-med Special No. 11: coated acupuncture needles with copper-wire handle|without guide tube|
• 04251282507312: asia-med Special+ 3050: coated acupuncture needles with rigid steel handle|with guide tube|Pack
• 04251282507282: asia-med Special+ 3040: coated acupuncture needles with rigid steel handle|with guide tube|Pack
• 04251282504663: asia-med Kinesiology Tape - White: made of cotton fabric with a medical grade acrylic adhesive
• 04251282504625: asia-med Kinesiology Tape - Red: made of cotton fabric with a medical grade acrylic adhesive ap
• 04251282504618: asia-med Kinesiology Tape - Yellow: made of cotton fabric with a medical grade acrylic adhesive
• 04251282504601: asia-med Kinesiology Tape - Green: made of cotton fabric with a medical grade acrylic adhesive
• 04251282504595: asia-med Kinesiology Tape Nylon - Blue color: made Nylon (82%) and Spandex (18%) with a medical
• 04251282504588: asia-med Kinesiology Tape Nylon - Tan color: made Nylon (82%) and Spandex (18%) with a medical
• 04251282504571: asia-med Kinesiology Tape - Light Purple: made of cotton fabric with a medical grade acrylic ad
• 04251282504564: asia-med Kinesiology Tape - Hot Green: made of cotton fabric with a medical grade acrylic adhes