FDA.reportPublic FDA data

Acu-Dispo-Curette

Primary DI
00814105020029
Brand
Acu-Dispo-Curette
Company
ACUDERM, INC.
Model
R03
Device description
Acu-Dispo-Curette 3mm, Single
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10814105020026PackageGS125In Commercial Distribution
20814105020023PackageGS150In Commercial Distribution
30814105020020PackageGS1100In Commercial Distribution
40814105020027PackageGS110In Commercial Distribution
00814105020029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081410502002610814105020026
2081410502002320814105020023
3081410502002030814105020020
4081410502002740814105020027
00814105020029008141050200298141050200290814105020029

GMDN Terms#

Term, Definition table
TermDefinition
Dermal curette, single-useA 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.

Regulatory Flags#

DUNS number
071426803
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00814105020005Acu-Dispo-CuretteR012020-09-22
00814105020012Acu-Dispo-CuretteR022020-09-22
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
00814105021316Acu-Dispo-CuretteRCOM2020-09-22

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