FDA.reportPublic FDA data

Tissue-Tek® Paraform®

Primary DI
10615233009033
Brand
Tissue-Tek® Paraform®
Company
SAKURA FINETEK U.S.A., INC.
Model
7043
Catalog number
7043
Device description
Tissue-Orientation Gel Strips, 20.0 x 2.6 mm
Published
2020-08-14
Public version status
Update
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
10615233009033PrimaryGS10
00615233009036Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061523300903310615233009033
00615233009036006152330090366152330090360615233009036

GMDN Terms#

Term, Definition table
TermDefinition
Histological tissue cassette biopsy insert IVDA flexible and porous material designed to securely hold a biopsy specimen within a tissue cassette, to prevent loss of the specimen during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination. The flexible and porous material (e.g., paper, synthetic polymer) is intended to allow infiltration of reagents and maximize fluid-exchange during tissue processing. It is available in various forms (e.g., sheet, bag, foam pad) and is placed in a tissue processing cassette, with the biopsy specimen wrapped or contained inside it. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags#

DUNS number
179135769
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615233000491Tissue-Tek Genie®8242-C0108242-C0102020-01-01
00615233000507Tissue-Tek Genie®8242-M2508242-M2502020-01-01
00615233000637Tissue-Tek Genie®8253-M2508253-M2502020-01-01
00615233000644Tissue-Tek Genie®8253-C0108253-C0102020-01-01
00615233011435Tissue-Tek Genie®8358-C0108358-C0102025-12-26
00615233011442Tissue-Tek Genie®8358-M2508358-M2502025-12-26
00615233013996Tissue-Tek Genie®8359-M2508359-M2502025-12-26
00615233014009Tissue-Tek Genie®8359-C0108359-C0102025-12-26
00615233014474Tissue-Tek Genie®8288-M2508288-M2502025-12-26
00615233014481Tissue-Tek Genie®8288-C0108288-C0102025-12-26
00615233014559Tissue-Tek Genie®8379-C0108379-C0102025-12-26
00615233014566Tissue-Tek Genie®8379-M2508379-M2502025-12-26
00615233011411Tissue-Tek Genie®8357-M2508357-M2502025-06-24
00615233011428Tissue-Tek Genie®8357-C0108357-C0102025-06-24
00615233013965Tissue-Tek Genie®8364-C0108364-C0102025-06-24
00615233013972Tissue-Tek Genie®8364-M2508364-M2502025-06-24
00615233010629Genemed®60-0226-1560-0226-152023-10-16
00615233003577Genemed®61-015461-01542023-07-05
00615233006066Genemed®60-0154-760-0154-72023-07-05
00615233008183Genemed®60-0221-1560-0221-152020-07-10

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