AccessGUDID - DEVICE: TUBBS MITRAL VALVE DILATOR (B09927001200)

GUDID

Device Identifier (DI) Information

Brand Name: TUBBS MITRAL VALVE DILATOR
Version or Model: 2700-120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09927001200
Issuing Agency: HIBCC
Commercial Distribution End Date: September 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: TUBBS MITRAL VALVE DILATOR

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?
11255	Mitral valve dilator	A hand-operated surgical instrument with specially designed expanding blades designed to dilate mitral stenosis during mitral valve surgery. It typically has forceps-like handles that include an adjustable, self-retaining mechanism to hold the blades at the desired expanded position. It is typically made of high-grade stainless steel and is available in various sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWP	Dilator, Vessel, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8 Millimeter

Device Record Status

Public Device Record Key: 60b1d347-4f06-45c6-9c42-54535e735460
Public Version Date: September 24, 2018
Public Version Number: 5
DI Record Publish Date: August 19, 2016