FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832026266
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
38441601
Catalog number
38441601
Device description
PM Biopsy Cassettes, Lid Attached, Pre-Load, Pink
Published
2025-07-20
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
20849832026260PrimaryGS10
00849832026266Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084983202626020849832026260
00849832026266008498320262668498320262660849832026266

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue cassette IVD, laboratory processing, single-useA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
770
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10849832027819Leica Biosystems380320038032002026-05-22
20849832027915Leica Biosystems39LP-200-239LP-200-22026-05-13
20849832027946Leica Biosystems39LP-200-539LP-200-52026-05-13
20849832027908Leica Biosystems39LP-200-139LP-200-12026-05-12
20849832027922Leica Biosystems39LP-200-339LP-200-32026-05-12
20849832027939Leica Biosystems39LP-200-439LP-200-42026-05-12
20849832027953Leica Biosystems39LP-200-639LP-200-62026-05-12
20849832027960Leica Biosystems39LP-200-739LP-200-72026-05-12
20849832027977Leica Biosystems39LP-300-039LP-300-02026-05-12
20849832027984Leica Biosystems39LP-300-139LP-300-12026-05-12
20849832027991Leica Biosystems39LP-300-239LP-300-22026-05-12
20849832028004Leica Biosystems39LP-300-339LP-300-32026-05-12
20849832028011Leica Biosystems39LP-300-439LP-300-42026-05-12
20849832028028Leica Biosystems39LP-300-539LP-300-52026-05-12
20849832028035Leica Biosystems39LP-300-639LP-300-62026-05-12
20849832028042Leica Biosystems39LP-300-739LP-300-72026-05-12
20849832028059Leica Biosystems39LP-400-039LP-400-02026-05-12
20849832028066Leica Biosystems39LP-400-139LP-400-12026-05-12
20849832028073Leica Biosystems39LP-400-239LP-400-22026-05-12
20849832028080Leica Biosystems39LP-400-339LP-400-32026-05-12

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