AccessGUDID - DEVICE: CORIOGRAPH (00885556917442)

GUDID

Device Identifier (DI) Information

Brand Name: CORIOGRAPH
Version or Model: ROB20030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ROB20030
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556917442
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46470	Orthopaedic/craniofacial implantation planning software	A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBF	Orthopaedic surgical planning and instrument guides
OOG	Knee arthroplasty implantation system
MBH	PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
HSX	PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240113	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e20460d-7dcc-4cca-8e95-35fcd59923fc
Public Version Date: March 04, 2025
Public Version Number: 2
DI Record Publish Date: November 07, 2024

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)238-7538
Email: GUDID@SMITH-NEPHEW.COM

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