AccessGUDID - DEVICE: TubaVent® balloon dilatation system (04250676745088)

GUDID

Device Identifier (DI) Information

Brand Name: TubaVent® balloon dilatation system
Version or Model: 2080-3045-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2080-3045-US
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250676745088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: TubaInsert ONE® - Type 45°, insertion device, sterile, 10 pieces

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:	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?
58115	Peripheral vascular guidewire, manual	A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNZ	Eustachian tube balloon dilation device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223542	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 72c55ca9-805a-4d77-906f-7223da02777d
Public Version Date: March 07, 2025
Public Version Number: 1
DI Record Publish Date: February 27, 2025