CORIOGRAPH ROB20030
GUDID 00885556917442
CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE
Smith & Nephew, Inc.
Orthopaedic/craniofacial implantation planning software| Primary Device ID | 00885556917442 |
| NIH Device Record Key | 7e20460d-7dcc-4cca-8e95-35fcd59923fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CORIOGRAPH |
| Version Model Number | ROB20030 |
| Catalog Number | ROB20030 |
| Company DUNS | 045483575 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556917442 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240113
FDA Product Code
| PBF | Orthopaedic surgical planning and instrument guides |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-15 |
| Device Publish Date | 2024-11-07 |
Devices Manufactured by Smith & Nephew, Inc.
| 00885556917442 - CORIOGRAPH | 2024-11-15CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE |
| 00885556917442 - CORIOGRAPH | 2024-11-15 CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE |
| 00885556919620 - R3 | 2024-11-14 R3 HEX ADAPTER |
| 00885556919637 - R3 | 2024-11-14 MAGNETIC T-HANDLE SOCKET WRENCH |
| 00885556919613 - R3 | 2024-11-12 OFFSET CUP IMPACTOR |
| 00885556000908 - Legion | 2024-11-05 1 Degree Varus/Valgus Recut Block |
| 00885556000915 - Legion | 2024-11-05 2 Degree Varus/Valgus Recut Block |
| 00885556920640 - NA | 2024-11-05 4.5mm Proximal Tibia Plate 4 Hole EVOS |
| 00885556920831 - Legion | 2024-11-05 Monolithic CR DF Trial Sz 3-4 - 18mm |
Trademark Results [CORIOGRAPH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORIOGRAPH 98184026 not registered Live/Pending |
Smith & Nephew, Inc. 2023-09-18 |
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