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
00860015267818EmbedMedCMFAMS-S2026-03-30
00860009815711EmbedMedCMFAMFEUS2023-05-23
00860009815728EmbedMedCMFSG2023-05-23
00860009815735EmbedMedCMFDAM2023-05-23
00860009815704EmbedMedCMFAMNS2023-02-20
00860009815759EmbedMedOTHSG2023-05-22
00860009815766EmbedMedOTHAMFEUS2023-05-23
00860009815773EmbedMedOTHAMNS2023-05-23
00860009815742EmbedMedOTHDAM2023-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08437021468175QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2025-07-04
07630542730153MyShoulder PlannerMedacta International SALLZ2025-02-06
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
08056304455727G-scan OpenESAOTE SPALLZ2024-07-02
08056600520044Nical Flat PanelNICAL SPALLZ2023-10-09
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
G221200CA3080iQ ViewFirst Source, Inc.LLZ2023-06-13
07630542715679Advanced MyHip PlannerMedacta International SALLZ2023-01-26
07630030855818MyHip bone modelMedacta International SALLZ2023-01-23
07630030855825MyHip bone modelMedacta International SALLZ2023-01-23
07630030855832MyHip bone modelMedacta International SALLZ2023-01-23
07630030855849MyHip bone modelMedacta International SALLZ2023-01-23
07630345729286Advanced MyHip PlannerMedacta International SALLZ2023-01-23
G2710300240140IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240150IntelliguidesMios Marketing, LLCPBF2023-01-01