FDA.reportPublic FDA data

AccuThrive®

Primary DI
00843382104092
Brand
AccuThrive®
Company
AccuTec, Inc.
Model
Biopsy Blade
Catalog number
AVSC-1130-0000
Device description
AccuThrive Dermablade Biopsy Blade SS Sterile 400BL/CA (50BL/CT 8CT/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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843382104108PackageGS150In Commercial Distribution
00843382104115PackageGS18In Commercial Distribution
00843382104092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843382104108008433821041088433821041080843382104108
00843382104115008433821041158433821041150843382104115
00843382104092008433821040928433821040920843382104092

GMDN Terms#

Term, Definition table
TermDefinition
Skin biopsy bladeA sterile hand-held device intended to be used to surgically remove a tissue specimen from a patient’s skin for histopathological examination (biopsy); it may also be used to remove skin lesions (e.g., skin moles). Sometimes referred to as a biopsy razor blade, it is in the form of a cutting blade, within a plastic case with side grips, which is flexible to help facilitate bending for precise tissue excision. 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
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
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27