AccessGUDID - DEVICE: HBW PINE (00816073021381)

GUDID

Device Identifier (DI) Information

Brand Name: HBW PINE
Version or Model: KA Type No.38G x 15mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KA3805
Company Name: HEALTH BODY WORLD SUPPLY, INC.

Primary DI Number: 00816073021381
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 061228290 *Terms of Use

Device Description: Painless HBW PINE needles are made of surgical stainless steel with 20mm long spring style metal handle without loop, Lightweight, affordable price with a high quality. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with colored holding tab for easy gauge identification. Box of 200 needles, Size 38G x 15mm.

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):	Yes

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
Device Size Text, specify: 0.18 x 15mm

Device Record Status

Public Device Record Key: 134bb0cf-0578-45a0-a359-9d83f0cbfa7b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 10, 2016