AccessGUDID - DEVICE: HBW UNISHARP (00816073022609)

GUDID

Device Identifier (DI) Information

Brand Name: HBW UNISHARP
Version or Model: L Type No.30G x 25mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L3010
Company Name: HEALTH BODY WORLD SUPPLY, INC.

Primary DI Number: 00816073022609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 061228290 *Terms of Use

Device Description: Painless HBW UNISHARP needles are made of surgical stainless steel with 25mm 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 without tab for easy gauge identification. Box of 100 needles, Size 30G x 25mm.

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: 2c43c44b-edc0-4c23-82e8-1268fc71ca34
Public Version Date: March 18, 2019
Public Version Number: 1
DI Record Publish Date: March 08, 2019