DEVICE: Montgomery® Thyroplasty Instrument (14063107102537)

Device Identifier (DI) Information

Montgomery® Thyroplasty Instrument
MT-205
In Commercial Distribution
MT-205
Boston Medical Products, Inc.
14063107102537
GS1

1
131855157 *Terms of Use
Small Curved Hook
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Device Characteristics

MR Unsafe
No
Yes
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
MIX System, Vocal Cord Medialization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K972317 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e646a1fc-87e3-4e65-8fc5-02732c78221c
September 08, 2022
1
August 31, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-433-2674
info@bosmed.com
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