Identity
- Trade Name
- Montgomery® Thyroplasty Instrument FDA UDI
- Generic Name
- ENT elevator FDA UDI
- Device Name
- Male Implant Inserter FDA UDI
- Model / Reference
- MT-213 FDA UDI
- Description
- Male Implant Inserter FDA UDI
Identifiers
- Catalog Number
- MT-213 FDA UDI
- Primary DI / UDI-DI
- 14063107102612 FDA UDI
- 510(k) Number
- K972317 FDA UDI
- FDA Product Code
- MIX FDA UDI
- GMDN Term
- ENT elevator 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
No
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 elevator
Montgomery® Thyroplasty Instrument by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0784537a-7c27-4b61-bb49-76fab95e4e56 37 fields · synced Jun 9, 2026