FDA.reportPublic FDA data

AcanthusTM

Primary DI
00860010482612
Brand
AcanthusTM
Company
Acanthus Medical Creations LLC
Model
NBP
Catalog number
NBP
Device description
Acanthus Nasal Bridge Protector (Bag of 100)
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010482643PrimaryGS10
00860010482667PrimaryGS10
00860010482612Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010482643008600104826438600104826430860010482643
00860010482667008600104826678600104826670860010482667
00860010482612008600104826128600104826120860010482612

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, siliconeA long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065124205
Device count
100
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010482674AcanthusANBP01979920DANBP01979920D2026-05-27
00860005762606AcanthusACC019796ACC019796, ACC0197963, ACC0197969, ACC019796022021-02-15
00860010482605AcanthusTMNCHNCH2023-06-05
00860010190845AcanthusANCH01980010ANCH019800102024-12-13
00860010190852AcanthusANCH01980020ANCH019800202024-12-13
00860010190838AcanthusANCH0198005ANCH01980052023-06-05
00860010482650AcanthusANBP01979912DANBP01979912D2025-07-28
00860010482629AcanthusANBP019799DANBP019799D2025-07-06
00860010190890AcanthusANBP01979915ANBP019799152025-05-17
00860010190876AcanthusANBP01979907ANBP019799072025-04-09
00860010190821AcanthusANBP01979920ANBP019799202024-12-03
00860010190807AcanthusANBP0197995ANBP01979952023-06-05
00860010190814AcanthusANBP01979910ANBP019799102024-12-03
00860005762668AcanthusANGTH019801ANGTH0198012023-08-04
00860005762620AcanthusACC019795ACC0197952021-03-15
00860005762637AcanthusANCH019800ANCH0198002023-06-05
00860010482643AcanthusTMNBPNBP2023-06-05
00860005762651AcanthusANBP019799ANBP0197992023-06-05
00860010482681AcanthusTMNCHNCH2023-06-05
00860005762613AcanthusACC019795ACC0197952021-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166028DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166035DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166073DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08