FDA.reportPublic FDA data

Acu-Dispo-Curette

Primary DI
00814105021323
Brand
Acu-Dispo-Curette
Company
ACUDERM, INC.
Model
RCOMPL
Device description
Acu-Dispo-Curette, Plus Assortment
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K891334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K891334000ACU-CURETTEAcuderm, Inc.1989-04-11FZS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814105021323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814105021323008141050213238141050213230814105021323

GMDN Terms#

Term, Definition table
TermDefinition
Dermal curetteA sterile, hand-held manual surgical instrument designed exclusively for the precise scraping and/or excising of skin/dermal tissue (e.g., for treatment of superficial warts or wounds). It is available in a variety of shapes/sizes and has an appropriately-shaped distal end (e.g., ring-like). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071426803
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814105020005Acu-Dispo-CuretteR012020-09-22
00814105020012Acu-Dispo-CuretteR022020-09-22
00814105020029Acu-Dispo-CuretteR032020-09-22
00814105020036Acu-Dispo-CuretteR042020-09-22
00814105020043Acu-Dispo-CuretteR052020-09-22
00814105020050Acu-Dispo-CuretteR072020-09-22
00814105020883Acu-PunchP12020-09-22
00814105020890Acu-PunchP1.52020-09-22
00814105020906Acu-PunchP22020-09-22
00814105020913Acu-PunchP2.52020-09-22
00814105020920Acu-PunchP32020-09-22
00814105020937Acu-PunchP3.52020-09-22
00814105020944Acu-PunchP42020-09-22
00814105020951Acu-PunchP4.52020-09-22
00814105020968Acu-PunchP52020-09-22
00814105020975Acu-PunchP62020-09-22
00814105020982Acu-PunchP72020-09-22
00814105020999Acu-PunchP82020-09-22
00814105021002Acu-PunchP102020-09-22
00814105021019Acu-PunchP122020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840314270290gSourceGSOURCE LLCFZS2026-08-07
00810143906592SURGIPROSSurgipros, LLCFZS2026-07-30
00810143906608SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909777SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909784SURGIPROSSurgipros, LLCFZS2026-07-30
00810143909807SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934136SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934143SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934150SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934167SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934174SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934181SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934198SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934204SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934211SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934228SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934235SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934242SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934259SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934266SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934273SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934280SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934297SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934303SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934310SURGIPROSSurgipros, LLCFZS2026-07-30
00810212934327SURGIPROSSurgipros, LLCFZS2026-07-30
07640221373717SCALASpineArt SAFZS2026-07-24
07640221373724SCALASpineArt SAFZS2026-07-24
07640221373731SCALASpineArt SAFZS2026-07-24
07640221373748SCALASpineArt SAFZS2026-07-24