FDA.reportPublic FDA data

EmbedMed

Primary DI
00860009815711
Brand
EmbedMed
Company
3D LIFEPRINTS UK LTD
Model
CMFAMFEUS
Device description
Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization
Published
2023-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220366000EmbedMed3D Lifeprints UK , Ltd.2022-09-30DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009815711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009815711008600098157118600098157110860009815711

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, and may be sterilized prior to use in sterile fields.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
220777297
Device count
1
Serial number
true
Expiration date on label
true
Sterilization required before use
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
00860009815797EmbedMedOTHAMS-S2026-03-30
00860015267818EmbedMedCMFAMS-S2026-03-30
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
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
05420060351235TRUMATCHMaterialise NVDZJ2026-10-22
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVDZJ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVDZJ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVDZJ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVDZJ2026-10-22
05420060351280TRUMATCHMaterialise NVDZJ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVDZJ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVDZJ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVDZJ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVDZJ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVDZJ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVDZJ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVDZJ2026-10-22
05420060351365TRUMATCHMaterialise NVDZJ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVDZJ2026-10-22