AccessGUDID - DEVICE: Micro TAC (00816073023019)

GUDID

Device Identifier (DI) Information

Brand Name: Micro TAC
Version or Model: 0.18 x 1.3mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23409
Company Name: HEALTH BODY WORLD SUPPLY, INC.

Primary DI Number: 00816073023019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 061228290 *Terms of Use

Device Description: acupuncture press needles with double tape, 0.18x1.3mm, 40pcs 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):	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: 0.16 x 30mm

Device Record Status

Public Device Record Key: 70df7708-4cc1-4ee5-903a-b1ff2d1c52f7
Public Version Date: January 18, 2022
Public Version Number: 1
DI Record Publish Date: January 10, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10816073023016 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-852-4609
Email: sami@buyacupuncture.com

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