FDA.reportPublic FDA data

Bstent (Large)

Primary DI
10860012025913
Brand
Bstent (Large)
Company
PS Devices, LLC
Model
7002
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
OTC
false
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
20860012025910PrimaryGS10
10860012025913Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086001202591020860012025910
1086001202591310860012025913

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
Height16.5Millimeter
Length76.7Millimeter
Width9.5Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119246141
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20860012025903Bstent (Small)70012024-10-28
20860012025910Bstent (Large)70022024-10-28
10860012025906Bstent (Small)70012024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16975560670066Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670073Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670080Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670097Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670103Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670110Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670257Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670264Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670271Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670288Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670295Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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06975560670076Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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06975560670090Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
26975560670100Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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