DEVICE: TEWA (04251282504335)

Device Identifier (DI) Information

TEWA
ID-Type 1205 Intradermal needle
Not in Commercial Distribution
A000561
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
04251282504335
GS1
June 30, 2018
100
327997797 *Terms of Use
TeWa ID-Type 1205 Intradermal needle: uncoated TeWa intradermal acupuncture needles with with a ring handle (hinai-shin).|Packaging: 1 needle per blister|Size: Gauge 02(x 0.2") / 0.12 x 5 mm|Color code: dark green|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 [?]
K132896 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
Length: 5 Millimeter
Outer Diameter: 0.12 Millimeter
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Device Record Status

9939245d-30e3-4f5e-91fd-16e967b29caa
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
4251282504342 10 04251282504335 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: 04251282504328 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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