FDA.reportPublic FDA data

Montgomery® Thyroplasty Instrument

Primary DI
14063107102490
Brand
Montgomery® Thyroplasty Instrument
Company
Boston Medical Products, Inc.
Model
MT-201
Catalog number
MT-201
Device description
7 mm Female Window Caliper
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIXSystem, Vocal Cord Medialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIXSystem, Vocal Cord MedializationEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972317000MONTGOMERY THYROPLASTY IMPLANT SYSTEMBoston Medical Products, Inc.1997-09-18MIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14063107102490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1406310710249014063107102490

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags#

DUNS number
131855157
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14063107102865Montgomery® Safe-T-Tube™ Plug/Ring Set3610863610862024-09-28
14063107102872Montgomery® Safe-T-Tube™ 15 mm Adaptor3610873610872024-09-28
14063107102889Montgomery® Safe-T-Tube™ Plug/Ring Set3611063611062024-09-28
14063107102896Montgomery® Safe-T-Tube™ 15 mm Adaptor3611073611072024-09-28
14063107102902Montgomery® Safe-T-Tube™ Plug/Ring Set3611163611162024-09-28
14063107102919Montgomery® Safe-T-Tube™ 15 mm Adaptor3611173611172024-09-28
14063107102926Montgomery® Safe-T-Tube™ Plug/Ring Set3611263611262024-09-28
14063107102933Montgomery® Safe-T-Tube™ 15 mm Adaptor3611273611272024-09-28
14063107102940Montgomery® Safe-T-Tube™ Plug/Ring Set3611463611462024-09-28
14063107102957Montgomery® Safe-T-Tube™ 15 mm Adaptor3611473611472024-09-28
14063107103060Montgomery® Safe-T-Tube™4600084600082024-09-28
14063107103077Montgomery® Safe-T-Tube™460008R460008R2024-09-28
14063107103084Montgomery® Safe-T-Tube™4600094600092024-09-28
14063107103091Montgomery® Safe-T-Tube™460009R460009R2024-09-28
14063107103107Montgomery® Safe-T-Tube™4600104600102024-09-28
14063107103114Montgomery® Safe-T-Tube™460010R460010R2024-09-28
14063107103121Montgomery® Safe-T-Tube™4600114600112024-09-28
14063107103138Montgomery® Safe-T-Tube™460011R460011R2024-09-28
14063107103145Montgomery® Safe-T-Tube™4600124600122024-09-28
14063107103152Montgomery® Safe-T-Tube™460012R460012R2024-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810235030846Prolaryn Gel MERZ NORTH AMERICA, INC.MIX2026-02-24
14063107101752Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101769Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101776Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101783Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101790Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101806Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101813Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101820Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101837Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101844Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101851Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101868Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102629Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
14063107102636Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
34063107101756Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101763Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101770Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101787Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101794Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101800Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101817Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101824Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101831Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101848Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101855Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101862Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102483Montgomery® Thyroplasty Instrument SetBoston Medical Products, Inc.MIX2022-08-31
14063107102506Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31
14063107102513Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31