DEVICE: TEWA (04251282507220)

Device Identifier (DI) Information

TEWA
KB-Type 2540
Not in Commercial Distribution
A000806
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
04251282507220
GS1
June 30, 2018
100
327997797 *Terms of Use
TeWa KB-Type 2540: coated acupuncture needles with Korean style, non-looped steel coil handle|without guide tube|Packaging: 1 needle per blister|Size: Gauge 5(x 1.5") / 0.25 x 40 mm|Color code: purple|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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34175 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.
Active false
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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 [?]
Premarket Submission Number Not Available/Not Released
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
Length: 40 Millimeter
Outer Diameter: 0.25 Millimeter
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Device Record Status

dfe7b24d-4520-4303-8b7e-1f87de5b11cd
March 27, 2023
6
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
4251282507237 10 04251282507220 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: 04251282507213 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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