AccessGUDID - DEVICE: Acufast The Earth Friendly Needle (00754028818153)

GUDID

Device Identifier (DI) Information

Brand Name: Acufast The Earth Friendly Needle
Version or Model: ANS18-1520GAS C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AFSC1815
Company Name: Eastern Currents Distributing Ltd

Primary DI Number: 00754028818153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 257053454 *Terms of Use

Device Description: Acufast needles are the world’s first consciously produced environmentally friendly acupuncture needle brand. The manufacturer has chosen low impact metals, reduced packaging sizes, used repurposed biodegradable materials for outer packages. These plus other features make this an exciting product for both ease insertion, performance, and reduction of waste. The needles are Spring handle style needles made from surgical grade stainless steel. They are machine sharpened for precision tips and are partially coated with medical grade silicone for a very smooth insertion. Acufast needles come vacuum sealed in pouch packs of 10 per pouch. There are 100 pouches with at total of 1000 needles in each box. Please note that tubes sold separately (no more wasted tubes).

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.18 mm x 15 mm

Device Record Status

Public Device Record Key: 6c9a882b-0710-4659-8314-a4b541c484da
Public Version Date: December 03, 2020
Public Version Number: 1
DI Record Publish Date: November 25, 2020