FDA UDI In Commercial Distribution 🇺🇸 United States

CORIOGRAPH

DI: 00885556921524 · Model: ROB2003002 · Smith & Nephew, Inc.
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CORIOGRAPH
Primary DI
00885556921524
Version / Model
ROB2003002
Catalog Number
ROB2003002
Company Name
Smith & Nephew, Inc.
Labeler DUNS
045483575
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-20
Public Version
1
Public Version Date
2024-11-28
Public Version Status
New
Public Device Record Key
96fcb4de-a8a6-41f4-a8d4-743b61392cee

Device Description

CORIOGRAPH Pre-Operative Planning and Modeling Services V2.0. Modules in scope: CORIOGRAPH Knee Pre-Op Plan CORIOGRAPH Hip Pre-Op Plan CORIOGRAPH Modeler

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PBF Orthopaedic surgical planning and instrument guides
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

GMDN Terms

Code Name
46470 Orthopaedic/craniofacial implantation planning software

Identifiers

Type ID
Primary 00885556921524

Customer Contacts