Integra® First Choice®

Primary DI
M269TRL600MED1
Brand
Integra® First Choice®
Company
Ascension Orthopedics, Inc.
Model
TRL600MED
Catalog number
TRL-600-MED
Device description
The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteotomy and simulate actual implant stem.
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10381780236757PrimaryGS10
M269TRL600MED1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178023675710381780236757

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
942377524
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

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