DEVICE: First Choice® DRUJ System (10381780246497)

Device Identifier (DI) Information

First Choice® DRUJ System
OSG60001
In Commercial Distribution
OSG-600-01
Ascension Orthopedics, Inc.
10381780246497
GS1
December 31, 2026
1
942377524 *Terms of Use
Integra® First Choice® DRUJ System MUH Osteotomy Guide The Modular Ulnar Head Osteotomy Guide attaches onto reamers and is used to determine a standard, medium, or long resection.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60826 Custom-made orthopaedic/craniofacial surgical guide
A 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 made of synthetic polymer materials and 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZX Guide, surgical, instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 2.09 in L x .768 in W x 1.0 in depth
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Device Record Status

3a17be77-7d7a-4a26-9510-c12a6a88397c
January 25, 2023
5
September 05, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC M269OSG600011
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)654-2873
custsvcnj@integralife.com
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