FDA.reportPublic FDA data

Bstent (Small)

Primary DI
20860012025903
Brand
Bstent (Small)
Company
PS Devices, LLC
Model
7001
Device description
Bstent combines the features and benefits of nostril dilators and septal stents into a single, dual-purpose device, without the need for fixation.
Published
2024-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860012025903PrimaryGS10
10860012025906Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086001202590320860012025903
1086001202590610860012025906

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height14.6Millimeter
Length76.7Millimeter
Width8.7Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
440-565-7112customerservice@bstentrhino.com

Regulatory Flags#

DUNS number
119246141
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20860012025910Bstent (Large)70022024-10-28
10860012025906Bstent (Small)70012024-10-28
10860012025913Bstent (Large)70022024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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