AccessGUDID - DEVICE: Prime (00807689000112)

GUDID

Device Identifier (DI) Information

Brand Name: Prime
Version or Model: 1640
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA-09-1640
Company Name: C A I INDUSTRIES CORP

Primary DI Number: 00807689000112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 859060303 *Terms of Use

Device Description: 0.16x40mm acupuncture needles (10 needles with 10 tubes per pack, 10 packs per box).

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

[?]

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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 1.5 Inch
Needle Gauge: 40 Gauge

Device Record Status

Public Device Record Key: ccb6f94e-584f-4617-9647-13a366dbaaba
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 03, 2017