FDA.reportPublic FDA data

Faset

Primary DI
08800039820332
Brand
Faset
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
FA.IN.3003
Device description
Dilator Small
Published
2019-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180729000FaSet Fixation SystemHuvexel Co. , Ltd.2018-06-28MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039820332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039820332088000398203328800039820332

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula dilatorA hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82313699470info@huvexel.com

Regulatory Flags#

DUNS number
557795909
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039800754Hana ACPAUP.IN.00052019-02-08
08800039802024Fortis ACPATP.IN.00032019-02-08
08800039829991Fortis ACPATPA.PL.01102019-07-19
08800039830003Fortis ACPATPA.PL.01122019-07-19
08800039830010Fortis ACPATPA.PL.01142019-07-19
08800039830027Fortis ACPATPA.PL.01162019-07-19
08800039830034Fortis ACPATPA.PL.01182019-07-19
08800039830041Fortis ACPATPA.PL.01202019-07-19
08800039830058Fortis ACPATPA.PL.02262019-07-19
08800039830065Fortis ACPATPA.PL.02282019-07-19
08800039830072Fortis ACPATPA.PL.02302019-07-19
08800039830089Fortis ACPATPA.PL.02322019-07-19
08800039830096Fortis ACPATPA.PL.02342019-07-19
08800039830102Fortis ACPATPA.PL.03432019-07-19
08800039830119Fortis ACPATPA.PL.03462019-07-19
08800039830126Fortis ACPATPA.PL.03492019-07-19
08800039830133Fortis ACPATPA.PL.03522019-07-19
08800039830140Fortis ACPATPA.PL.03552019-07-19
08800039830157Fortis ACPATPA.PL.03582019-07-19
08800039830188Fortis ACPATPA.PL.01222019-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867614543Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614550Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614567Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614574Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614581Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614598Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614604Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614611Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614628Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614635Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614642Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614659Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614666Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614673Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614680Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614697Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614703Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614710Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614727Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614734Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614741Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614758Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614765Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614772Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614789Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614796Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614802Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614819Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614826Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614833Arthrex®ARTHREX, INC.MRW2026-10-07