FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647023945
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
M492-7FS
Catalog number
15182701F
Device description
FB HISTOSETTE II PCH 1500/CS
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
20613647023949PackageGS11In Commercial Distribution
00613647023945PrimaryGS10
10613647023942Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702394920613647023949
00613647023945006136470239456136470239450613647023945
1061364702394210613647023942

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.

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
1500
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855904Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855911Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855928Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855935Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
20849832018302Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2026-04-30
10194484321663N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321670N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321687N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321694N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321700N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321717N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321755N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321212N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321229N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321359N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321366N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321373N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321380N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321397N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321403N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10849832001000Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001017Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001024Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001031Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001048Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001055Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832003097Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025822Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025839Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23