AccessGUDID - DEVICE: MICTEC SPRAY NOZZLE (00192896008861)

GUDID

Device Identifier (DI) Information

Brand Name: MICTEC SPRAY NOZZLE
Version or Model: 20943-60
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20943-60
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896008861
Issuing Agency: GS1
Commercial Distribution End Date: August 11, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: MICTEC SPRAY NOZZLE WITH BELLOWS FOR TALC POWDER WITH ROTABLE CONNECTION TUBE DOUBLE ANGLED

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:	No
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?
33466	ENT powder applicator	An applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002877	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 300 Millimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: aabeaf15-8200-4461-8f56-2ae6a7205c8c
Public Version Date: August 14, 2023
Public Version Number: 2
DI Record Publish Date: August 15, 2018