FDA.reportPublic FDA data

Embedding Cassette

Primary DI
00810049681494
Brand
Embedding Cassette
Company
TYPENEX MEDICAL LLC
Model
EC0303AXT
Device description
Biopsy, One Compartment, 1.6 x 1.6 mm, 45°, Lid Attached, Back Hinge, Aqua, Taped
Published
2022-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IDZCassettes, Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810049681494PrimaryGS10
00812269035736Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810049681494008100496814948100496814940810049681494
00812269035736008122690357368122690357360812269035736

GMDN Terms#

Term, Definition table
TermDefinition
Tissue embedding mould IVD, single-useA plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
2000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810050855850Microscope SlidesPS0404G2026-05-14
10810050855867Microscope SlidesPS0404L2026-05-14
10810050855874Microscope SlidesPS0404N2026-05-14
10810050855881Microscope SlidesPS0404P2026-05-14
10810050855898Microscope SlidesPS0404Y2026-05-14
10810050855904Embedding CassetteEC0616YXT-LASER2026-05-14
10810050855911Embedding CassetteEC0616PXT-LASER2026-05-14
10810050855928Embedding CassetteEC0616WXT-LASER2026-05-14
10810050855935Embedding CassetteEC0616EXT-LASER2026-05-14
10810050855843Rad ControlRT0301XBA2026-05-06
10810050855836Microscope SlidesLC0105B2026-03-23
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000020Sterile LabelsSL-1000022026-03-17
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050851923Specimen Collection SwabSW0202SW02022020-06-01
00810050851909Specimen Collection SwabSW0102SW01022020-06-01
00810050852388Anterior Nasal SwabSW0302SW03022020-08-20
00810050855815ThermoFlo®60612026-01-26
00810050855808Typenex Introducer SetMS2335S2025-11-17
10810050855805Typenex Introducer SetMS2335S2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051663626927EprediaSHANDON DIAGNOSTICS LIMITEDIDZ2026-03-11
20194484321660N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321677N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321684N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321691N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321707N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321714N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321752N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
20194484321219N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321226N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321356N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321363N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321370N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321387N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321394N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
20194484321400N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
00849832001003Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001010Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001027Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001034Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001041Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832001058Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832003090Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025818Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025825Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832025832Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
00849832000808Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002567Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002918Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20
00849832002925Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-20