FDA.reportPublic FDA data

Rutter Stent

Primary DI
EBES8400060
Brand
Rutter Stent
Company
Boston Medical Products, Inc.
Model
840006
Catalog number
840006
Device description
Size: 6 mm; Type: Radiopaque
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWNProsthesis, Larynx (Stents And Keels)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWNProsthesis, Larynx (Stents And Keels)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091135000RUTTER SUPRA STOMAL STENTSBoston Medical Products, Inc.2009-09-14FWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBES8400061PackageHIBCC1In Commercial Distribution
EBES8400060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric laryngeal stentA sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively. It is typically a hollow, semi-soft moulded device made of a synthetic polymer(s) (e.g., silicone) intended to conform to the endolaryngeal surface. Disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length83Millimeter
Outer Diameter6Millimeter

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
14063107101646Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101653Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101660Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101677Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101684Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101691Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101707Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101714Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101721Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101738Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107100441Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100465Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100472Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100489Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100496Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100502Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100519Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100526Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100533Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100540Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100445Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100469Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100476Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100483Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100490Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100506Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100513Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100520Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100537Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100544Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29