AccessGUDID - DEVICE: TEWA (04251282504397)

GUDID

Device Identifier (DI) Information

Brand Name: TEWA
Version or Model: ID-Type 1605 Intradermal needle
Catalog Number: A000563
Company Name: asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG

Primary DI Number: 04251282504397
Issuing Agency: GS1
Device Count: 100

Device Description: TeWa ID-Type 1605 Intradermal needle: uncoated TeWa intradermal acupuncture needles with with a ring handle (hinai-shin).|Packaging: 1 needle per blister|Size: Gauge 1(x 0.2") / 0.16 x 5 mm|Color code: red|Sales unit: 100 pieces

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

FDA Product Code

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Product Code	Product Code Name
MQX	Needle, Acupuncture, Single Use

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 8 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 5 Millimeter
Outer Diameter: 0.16 Millimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: August 30, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
4251282504403	10	04251282504397		In Commercial Distribution	parcel

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: TEWA (04251282504397)