FDA.reportPublic FDA data

AccuThrive®

Primary DI
00843382104245
Brand
AccuThrive®
Company
AccuTec, Inc.
Model
Scalpel Blade
Catalog number
AVBL-1021-0000
Device description
AccuThrive #11 Surgical Blade SS MicroCoat Sterile 500BL/CA (100BL/CT 5CT/CA)
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBlade, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843382104242PackageGS15In Commercial Distribution
00843382104245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084338210424210843382104242
00843382104245008433821042458433821042450843382104245

GMDN Terms#

Term, Definition table
TermDefinition
Manual scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. 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
Expiration date on label
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
00843382104016AccuThrive®Microtome BladeAVBL-2005-00002024-12-17
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
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
00840456201701JMUJMU DENTAL, INCGES2026-06-22
00840456201718JMUJMU DENTAL, INCGES2026-06-22
00840456201725JMUJMU DENTAL, INCGES2026-06-22
00840456201732JMUJMU DENTAL, INCGES2026-06-22
00840456201749JMUJMU DENTAL, INCGES2026-06-22
00840456203170JMUJMU DENTAL, INCGES2026-06-22
00840456203187JMUJMU DENTAL, INCGES2026-06-22
00840456203194JMUJMU DENTAL, INCGES2026-06-22
00840456203200JMUJMU DENTAL, INCGES2026-06-22
00840456203217JMUJMU DENTAL, INCGES2026-06-22
00840456215692JMUJMU DENTAL, INCGES2026-06-22
00840456215708JMUJMU DENTAL, INCGES2026-06-22
00840456215715JMUJMU DENTAL, INCGES2026-06-22
00840456215722JMUJMU DENTAL, INCGES2026-06-22
00840456215920JMUJMU DENTAL, INCGES2026-06-22
00840456215937JMUJMU DENTAL, INCGES2026-06-22
00840456215944JMUJMU DENTAL, INCGES2026-06-22
00840456215951JMUJMU DENTAL, INCGES2026-06-22
00840456215968JMUJMU DENTAL, INCGES2026-06-22
00840456215982JMUJMU DENTAL, INCGES2026-06-22
00840456215999JMUJMU DENTAL, INCGES2026-06-22
00840456216002JMUJMU DENTAL, INCGES2026-06-22
00840456220641JMUJMU DENTAL, INCGES2026-06-22
00840456220658JMUJMU DENTAL, INCGES2026-06-22
00840456220665JMUJMU DENTAL, INCGES2026-06-22
00840456220672JMUJMU DENTAL, INCGES2026-06-22
00840456220689JMUJMU DENTAL, INCGES2026-06-22
00840456220696JMUJMU DENTAL, INCGES2026-06-22
00840456220702JMUJMU DENTAL, INCGES2026-06-22
00840456220719JMUJMU DENTAL, INCGES2026-06-22