FDA.reportPublic FDA data

EmbedMed

Primary DI
00860009815797
Brand
EmbedMed
Company
3D LIFEPRINTS UK LTD
Model
OTHAMS-S
Device description
Sterile Patient-specific, Orthopedic Anatomical Model
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009815797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009815797008600098157978600098157970860009815797

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.

Regulatory Flags#

DUNS number
220777297
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009815780EmbedMedOTHSG-S2026-03-30
00860015267801EmbedMedCMFSG-S2026-03-30
00860009815728EmbedMedCMFSG2023-05-23
00860009815759EmbedMedOTHSG2023-05-22
00860015267818EmbedMedCMFAMS-S2026-03-30
00860009815711EmbedMedCMFAMFEUS2023-05-23
00860009815735EmbedMedCMFDAM2023-05-23
00860009815704EmbedMedCMFAMNS2023-02-20
00860009815766EmbedMedOTHAMFEUS2023-05-23
00860009815773EmbedMedOTHAMNS2023-05-23
00860009815742EmbedMedOTHDAM2023-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00810007633282AccuStride SystemMedcadPBF2025-06-30
00810007633299AccuStride SystemMedcadPBF2025-06-30
00810007633305AccuStride SystemMedcadPBF2025-06-30
00810007633312AccuStride SystemMedcadPBF2025-06-30
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00810007633244AccuStride SystemMedcadPBF2025-06-10
00810111224680TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00810111224697TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00081000763324AccuStride SystemMedcadPBF2025-05-05
00810007633251AccuStride SystemMedcadPBF2025-05-05
00810007633268AccuStride SystemMedcadPBF2025-05-05
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00810111223553TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223560TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223577TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223584TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223447TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223454TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223478TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223621TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14