AccessGUDID - DEVICE: Montgomery® Thyroplasty Instrument Set (EBESMT2001)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Thyroplasty Instrument Set
Version or Model: MT-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT-200
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESMT2001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT-208, MT-209, MT-210, MT-211, MT-212, & MT-213.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
44067	ENT surgical procedure kit, non-medicated, reusable	A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.	Active	false

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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
No Device Sizes

Device Record Status

Public Device Record Key: 5c8505f7-9f47-4e5a-95b4-b4820ce8a7bf
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015