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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
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10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18