AccessGUDID - DEVICE: MT (06932503571067)

GUDID

Device Identifier (DI) Information

Brand Name: MT
Version or Model: MTPUMP-5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503571067
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: The Disposable Control Button is a component in the Fluid Pump System and has only one specification

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":	Yes
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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47890	Disposable surgical irrigation/aspiration system	A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	Lavage, Jet

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211172	000

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
No Device Sizes

Device Record Status

Public Device Record Key: b95d8e6e-70eb-44b7-a562-614010ccd8e6
Public Version Date: August 15, 2024
Public Version Number: 2
DI Record Publish Date: August 11, 2023