FDA.reportPublic FDA data

Redemption

Primary DI
00841731135391
Brand
Redemption
Company
VILEX LLC
Model
RD-K175-07S
Device description
Trocar
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231343000Redemption Duo Hindfoot Nail SystemVilex, LLC2024-01-30HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731135391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731135391008417311353918417311353910841731135391

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00NA

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-5002info@vilex.com

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450735916Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735906Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735920Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735944Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735968Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735975Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735999Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736033Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736057Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736071Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736118Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736132Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736149Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736187Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736224Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736262Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736309Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736361Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736385Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736439Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736446Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736491Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736507Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736552Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739317Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739348Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739379Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
00810212933825SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933832SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933849SURGIPROSSurgipros, LLCDRC2026-07-28