EmbedMed
GUDID 00860009815759
Patient-specific, Orthopedic Surgical Guide
3D LIFEPRINTS UK LTD
Custom-made orthopaedic/craniofacial surgical guide| Primary Device ID | 00860009815759 |
| NIH Device Record Key | 63cbfdb1-f762-4e07-b8f5-c5ef7d966c93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EmbedMed |
| Version Model Number | OTHSG |
| Company DUNS | 220777297 |
| Company Name | 3D LIFEPRINTS UK LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009815759 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221943
FDA Product Code
| PBF | Orthopaedic Surgical Planning And Instrument Guides |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
[00860009815759]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-30 |
| Device Publish Date | 2023-05-22 |
On-Brand Devices [EmbedMed]
| 00860009815704 | Patient-specific, Maxillofacial Anatomical Model, Non-sterile |
| 00860009815773 | Patient-specific, Orthopedic Anatomical Model, Non-sterile |
| 00860009815766 | Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization |
| 00860009815759 | Patient-specific, Orthopedic Surgical Guide |
| 00860009815742 | Patient-specific, Othopedic Anatomical Model, Digital |
| 00860009815735 | Patient-specific, Maxillofacial Anatomical Model, Digital |
| 00860009815728 | Patient-specific, Maxillofacial Surgical Guide |
| 00860009815711 | Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization |
Trademark Results [EmbedMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMBEDMED 90815959 not registered Live/Pending |
3D Lifeprints UK Limited 2021-07-07 |
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