AccessGUDID - DEVICE: Montgomery® Thyroplasty Instrument (EBESMT2060)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Thyroplasty Instrument
Version or Model: MT-206
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT-206
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESMT2060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Large Curved Hook

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:	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?
33434	ENT retractor	A surgical instrument for separating or drawing aside the margins of a surgical incision made during ear/nose/throat (ENT) surgery or various structures of these anatomical locations. It can have various designs, e.g., double or single-ended with a flat or curved, single or split, hook-like blade, or have a pointed hook formed at various angles. It is made of high-grade stainless steel. This is a reusable device.	Obsolete	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 away from sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c88f92b8-b563-471d-9f81-7ae50004c9a5
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015