FDA.reportPublic FDA data

SPIWay

Primary DI
00860003136416
Brand
SPIWay
Company
SPIWAY LLC
Model
SP005
Catalog number
SP005
Device description
SPIWay Endonasal Access Guide Size Medium
Published
2020-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180141000SPIWay Endonasal Access GuideSpiway, LLC2018-02-16LYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003136416PrimaryGS10
10860003136413Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003136416008600031364168600031364160860003136416
1086000313641310860003136413

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-565-1226orders@spiway.com

Regulatory Flags#

DUNS number
053144550
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003136409SPIWaySP004SP0042020-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011696353TurbAlignSPIRAIR, INC.LYA2026-10-14
00860011696360TurbAlignSPIRAIR, INC.LYA2026-10-14
00860008863348BleedCEASE®Carencease Healthcare LLCLYA2026-10-07
10850056665305ORCA FoamOrca Products, LLCLYA2026-05-07
16975560670042Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
16975560670059Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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
16975560670301Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670045Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
06975560670052Nasal Hemostasis SpongeNeo Modulus (Shandong) Medical Sci-Tech Co., Ltd.LYA2026-03-20
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04250676730008MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731104Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731111Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731128Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676731135Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
04250676741691Expanding nasal tamponSpiggle & Theis Medizintechnik GmbHLYA2025-10-07
00850056665193ORCA Foam Orca Products, LLCLYA2025-02-25
10860008863307BleedCEASE®Carencease Healthcare LLCLYA2024-12-10