FDA.reportPublic FDA data

First Choice® DRUJ System

Primary DI
10381780246480
Brand
First Choice® DRUJ System
Company
Ascension Orthopedics, Inc.
Model
OSG60000
Catalog number
OSG-600-00
Device description
Integra® First Choice® DRUJ System MUH Resection Guide The Modular Ulnar Head Resection Guide is placed against the distal ulna to determine a standard, medium, or long resection of the ulnar head.
Published
2017-09-05
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780246480PrimaryGS10
M269OSG600001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178024648010381780246480

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use 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
true
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
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
10381780246497First Choice® DRUJ SystemOSG60001OSG-600-012017-09-05
10381780246503First Choice® DRUJ SystemOSG610001OSG-610-0012017-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112590036MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590043MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590050MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590067MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590098MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590104MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590128MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590135MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590142MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590180MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590197MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590203MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590210MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590227MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590234MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590241MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590258MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590265MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590272MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590289MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590319MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590326MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590333MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590357MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590364MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05
00810112590371MOTOBAND CPCROSSROADS EXTREMITY SYSTEMSFZX2023-12-05