AccessGUDID - DEVICE: Montgomery® Thyroplasty Instrument (14063107102537)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Thyroplasty Instrument
Version or Model: MT-205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT-205
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107102537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Small 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?
42595	Soft-tissue surgical hook, reusable	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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: e646a1fc-87e3-4e65-8fc5-02732c78221c
Public Version Date: September 08, 2022
Public Version Number: 1
DI Record Publish Date: August 31, 2022