Ascension® First Choice® DRUJ System

Primary DI
10381780120704
Brand
Ascension® First Choice® DRUJ System
Company
Ascension Orthopedics, Inc.
Model
MUH600S45MWW
Catalog number
MUH-600-S45M-WW
Device description
Ulnar Implant, Head
Published
2017-10-09
Public version status
Update
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
KXEPROSTHESIS, WRIST, HEMI-, ULNAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXEProsthesis, Wrist, Hemi-, UlnarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112481000FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension Orthopedic2012-04-09KXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780120704PrimaryGS10
M268MUH600S45MWW1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012070410381780120704

GMDN Terms#

Term, Definition table
TermDefinition
Wrist ulna-head prosthesisA sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240204Cadence™102030222016-08-24
10381780240211Cadence™10203023102030232016-08-24
10381780240228Cadence™10203024102030242016-08-24
10381780240235Cadence™102030252016-08-24
10381780240242Cadence™102030262016-08-24
10381780240754Cadence™10204202102042022016-08-24
10381780245612Titan™IMC096004301IMC-0960-043-012017-08-30
10381780246374Integra®OSG20000OSG-200-002017-08-30
10381780246381Integra®OSG20010POSG-200-10P2017-08-30
10381780246398Integra®OSG20010PVOSG-200-10PV2017-08-30
10381780246404Integra®OSG20020POSG-200-20P2017-08-30
10381780246411Integra®OSG20020PVOSG-200-20PV2017-08-30
10381780246428Integra®OSG20030POSG-200-30P2017-08-30
10381780246435Integra®OSG20030PVOSG-200-30PV2017-09-05
10381780246442Integra®OSG20040POSG-200-40P2017-09-05
10381780246459Integra®OSG20040PVOSG-200-40PV2017-08-30
10381780246466Integra®OSG35001OSG-350-012017-08-30
10381780246473Integra®OSG44200OSG-442-002017-09-05
10381780246480First Choice® DRUJ SystemOSG60000OSG-600-002017-09-05
10381780246497First Choice® DRUJ SystemOSG60001OSG-600-012017-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556826621First Choice DRUJ and MUHSmith & Nephew, Inc.KXE2023-06-16
00885556826461First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826478First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826485First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826492First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826508First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826515First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826522First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826539First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826546First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826553First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826560First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826577First Choice Partial Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826584First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826591First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826607First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826614First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826195First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826201First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826218First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826225First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826232First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826249First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826256First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826263First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826270First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826287First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826294First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
00885556826300First Choice Modular Ulnar Head ImplantSmith & Nephew, Inc.KXE2022-12-21
B013DRUJB10200NAAPTIS MEDICAL, LLCKXE2021-08-27