FDA.reportPublic FDA data

Montgomery® Thyroplasty Measuring Kit

Primary DI
34063107102623
Brand
Montgomery® Thyroplasty Measuring Kit
Company
Boston Medical Products, Inc.
Model
MT-300
Catalog number
MT-300
Device description
Type: Female
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
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
34063107102623PackageGS11In Commercial Distribution
14063107102629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3406310710262334063107102623
1406310710262914063107102629

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA 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 single-use 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

Contacts#

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

Regulatory Flags#

DUNS number
131855157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
14063107102490Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31
14063107102506Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31