FDA.reportPublic FDA data

AccuThrive®

Primary DI
00843382104016
Brand
AccuThrive®
Company
AccuTec, Inc.
Model
Microtome Blade
Catalog number
AVBL-2005-0000
Device description
AccuThrive Agility Microtome Blade High Profile SS Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IDLMicrotome, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDLMicrotome, AccessoriesPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843382104013PackageGS110In Commercial Distribution
00843382104016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084338210401310843382104013
00843382104016008433821040168433821040160843382104016

GMDN Terms#

Term, Definition table
TermDefinition
Microtome blade IVD, single-useA flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that has been fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto slides for staining and then viewing with a microscope. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(800) 336-4061customerservice@atblades.com

Regulatory Flags#

DUNS number
079966794
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843382103972AccuThrive®Microtome BladeAVBL-2004-00002024-12-17
00843382104009AccuThrive®Microtome BladeAVBL-2007-00002024-12-17
00843382104023AccuThrive®Microtome BladeAVBL-2006-00002024-12-17
00843382104030AccuThrive®Microtome BladeAVBL-2008-00002024-12-17
00843382104047AccuThrive®Microtome BladeAVBL-2009-00002024-12-17
00843382104054AccuThrive®Microtome BladeAVBL-2010-00002024-12-17
00843382104061AccuThrive®Microtome BladeAVBL-2011-00002024-12-17
00843382104078AccuThrive®Microtome BladeAVBL-2020-00002024-12-17
00843382104085AccuThrive®Microtome BladeAVBL-2021-00002024-12-17
00843382104092AccuThrive®Biopsy BladeAVSC-1130-00002024-12-17
00843382104238AccuThrive®Scalpel BladeAVBL-1001-00002024-12-17
00843382104245AccuThrive®Scalpel BladeAVBL-1021-00002024-12-17
00843382104252AccuThrive®Scalpel BladeAVBL-1031-00002024-12-17
00843382104283AccuThrive®Microtome BladeAVBL-2022-00002024-12-17
00843382104290AccuThrive®Microtome BladeAVBL-2023-00002024-12-17
00843382105198AccuThrive®Scalpel BladeAVBL-1041-00002024-12-17
00843382105204AccuThrive®Scalpel BladeAVBL-1051-00002024-12-17
00843382105211AccuThrive®Scalpel BladeAVBL-1071-00002024-12-17
00843382105228AccuThrive®Scalpel BladeAVBL-1081-00002024-12-17
00843382105372AccuThrive®Scalpel BladeAVBL-1061-00002024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843382103972AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104009AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104023AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104030AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104047AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104054AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104061AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104078AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104085AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104283AccuThrive®AccuTec, Inc.IDL2024-12-17
00843382104290AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382103979AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104006AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104013AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104020AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104037AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104044AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104051AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104068AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104075AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104082AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104280AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104297AccuThrive®AccuTec, Inc.IDL2024-12-17
00673693063494EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063500EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063753EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063760EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063777EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063784EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063791EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29