AccessGUDID - DEVICE: TEWA (04251282504397)

GUDID

Device Identifier (DI) Information

Brand Name: TEWA
Version or Model: ID-Type 1605 Intradermal needle
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A000563
Company Name: asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG

Primary DI Number: 04251282504397
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2018
Device Count: 100
Labeler D-U-N-S® Number*: 327997797 *Terms of Use

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132896	000

Device Exempt from Premarket Submission: No CLOSE

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

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

Device Record Status

Public Device Record Key: fbad3bff-1b43-4ef9-b730-4c7f88d04263
Public Version Date: July 06, 2018
Public Version Number: 5
DI Record Publish Date: August 30, 2016