AccessGUDID - DEVICE: Montgomery® Thyroplasty Implant (EBESMTM080)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Thyroplasty Implant
Version or Model: MTM-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTM-08
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESMTM080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: Male 8

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
46942	Preformed vocal cord medialization implant	A solid, implantable device used for vocal cord medialization thyroplasty (removal of a "window" of cartilage from the outside of the voice box and replacing it with a prosthesis to push a paralyzed vocal cord toward the middle of the voice box) to treat patients with unilateral vocal cord paralysis to improve voice quality. It is available in a variety of shapes, materials [e.g., titanium (Ti), silicon, hydroxyapatite - also know as hydroxylapatite (HA)], and sizes (e.g., male and female). It can be adjusted intraoperatively to exactly fit the anatomic specifications of the patient, and may or may not be held in place with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIX	System, Vocal Cord Medialization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972317	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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: Male 8

Device Record Status

Public Device Record Key: a8cbb0e5-eb82-40a6-aca7-2e8503c45977
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015