DEVICE: ASIA MED (04251282504243)

Device Identifier (DI) Information

ASIA MED
PTN - large
Not in Commercial Distribution
A000555
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
04251282504243
GS1
June 30, 2018
100
327997797 *Terms of Use
asia-med PTN - large: uncoated semi-permanent acupuncture Press Tack Needle (PTN)|Packaging: 10 needles on plastic carrier|Size: Gauge 5(x 0.07") / 0.26 x 1.8 mm|Sales unit: 100 pieces
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Acupuncture needle, single-use A 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.
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FDA Product Code

[?]
Product Code Product Code Name
MQX Needle, Acupuncture, Single Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042063 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 8 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.26 Millimeter
Length: 1.8 Millimeter
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Device Record Status

91db49bb-8442-4b4c-b73d-c4d739085ed8
July 06, 2018
5
August 30, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
4251282504250 24 04251282504243 2018-06-30 Not in Commercial Distribution parcel
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04251282504236 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+49897473150
info@asiamed.com
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