FDA.reportPublic FDA data

Fisherbrand

Primary DI
30613647024202
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
M502-6FS
Catalog number
15182706E
Device description
FB MICROSTTE CSSTE BLU 250/PK
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
20613647024205PackageGS11In Commercial Distribution
30613647024202PackageGS14In Commercial Distribution
00613647024201PrimaryGS10
10613647024208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702420520613647024205
3061364702420230613647024202
00613647024201006136470242016136470242010613647024201
1061364702420810613647024208

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

Contacts#

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

Regulatory Flags#

DUNS number
004321519
Device count
250
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20613647010901FisherbrandSC-150-100135001002025-04-30
20613647010918FisherbrandSC-180-100135001012025-04-30
20613647010925FisherbrandSC-220-100135001022025-04-30
20613647010932FisherbrandSC-250-100135001032025-04-30
20613647018846Fisherbrand23101000231010002025-04-30
20613647018853Fisherbrand23101001231010012025-04-30
20613647018860Fisherbrand23101002231010022025-04-30
20613647018877Fisherbrand23101003231010032025-04-30
20613647018884Fisherbrand23101004231010042025-04-30
20613647018891Fisherbrand23101005231010052025-04-30
20613647024847Fisherbrand19-041-372B19041372B2025-04-30
30613647024851Fisherbrand19-041-372C19041372C2025-04-30
20613647024861Fisherbrand19-041-372D19041372D2025-04-30

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