DEVICE: Dana Acupuncture needle Blister 10T (08800023303322)

Device Identifier (DI) Information

Dana Acupuncture needle Blister 10T
ANS20-3020E
In Commercial Distribution

DANA medical.co.ltd
08800023303322
GS1

1
689851191 *Terms of Use
Dana Acupuncture Needles are high quality bulk packaged needles in Blister. Dana Acupuncture Needles are manufactured by Dana Medical Co., Ltd. with the most advanced automatic manufacturing facility of Acupuncture needles in Korea with Excellent needle tip polishing technology allowing you smooth insertion feeling of needles into patient's body. Dana Acupuncture Needle Blister 10T contains 10 needles with 1 guide tube per sterile Blister packages in a Box of 1,000 needles.
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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. 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

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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
Yes CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1a2ba96d-bfdf-4f91-ad99-356968ced7c3
December 02, 2021
1
November 24, 2021
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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
08800023303315 100 08800023303322 In Commercial Distribution Small inner box
08800023303308 10 08800023303315 In Commercial Distribution Middle inner box
08800023303292 10 08800023303308 In Commercial Distribution Carton box
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+82613949288
okdana1@hanmail.net
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