FDA.reportPublic FDA data

AccuThrive®

Primary DI
00843382104108
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079966794
Device count
1
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
false
Expiration date on label
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29
B356KE392100American MedicalsAmerican MedicalsMDM2026-05-29
B356KE396100American MedicalsAmerican MedicalsMDM2026-05-29
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29