AccessGUDID - DEVICE: HBW KB (00816073021978)

GUDID

Device Identifier (DI) Information

Brand Name: HBW KB
Version or Model: B Type No.36G x 30mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B3610
Company Name: HEALTH BODY WORLD SUPPLY, INC.

Primary DI Number: 00816073021978
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 061228290 *Terms of Use

Device Description: High quality bulk packaged needles at an economical price. Sterile disposable, surgical stainless steel acupuncture needles with FLAT top of 25 mm "spring" style metal handle. 10 needles with 1 insertion tube per sterile bulk package. Box of 1000 needles. Size:36Gauge x 30mm

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: 0.20 x 30mm

Device Record Status

Public Device Record Key: 2d13dd17-06d4-4f8d-ad01-1e42bc9e21ee
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2016