Identity
- Trade Name
- Montgomery® Thyroplasty Instrument Set FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MT-200 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- MT-200 FDA UDI
- Primary DI / UDI-DI
- EBESMT2001 FDA UDI
- 510(k) Number
- K972317 FDA UDI
- FDA Product Code
- MIX FDA UDI
- GMDN Term
- ENT surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: ENT surgical procedure kit, non-medicated, reusable
Montgomery® Thyroplasty Instrument Set by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT surgical procedure kit, non-medicated, reusable.
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- ELMED — ELMED INCORPORATED · Class I
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- ELMED — ELMED INCORPORATED · Class I
Cleared under the same submission
K972317 also covers:
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 5c8505f7-9f47-4e5a-95b4-b4820ce8a7bf 37 fields · synced Jun 9, 2026