FDA.reportPublic FDA data

Dong-A Pharmaceutical Co., Ltd.

Primary DI
08806011816621
Brand
Dong-A Pharmaceutical Co., Ltd.
Company
Dong-A Pharmaceutical Co., Ltd.
Model
FATION NOSCA9 SPOT PATCH
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806011816720PrimaryGS10
08806011816621Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806011816720088060118167208806011816720
08806011816621088060118166218806011816621

GMDN Terms#

Term, Definition table
TermDefinition
Wound shieldA mechanical shield that is designed to form a protective structure over a wound. It may be cage-like and will allow exposure to air and permit access to the injured area while protecting against accidental damage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688733015
Device count
2
DM exempt
false
Premarket exempt
true
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
08806011632863Dong-A Pharmaceutical Co., Ltd. Tempo Tampon Regular2023-02-14
08806011633242Dong-A Pharmaceutical Co., Ltd. Tempo Tampon Super2023-02-14
08806011635697Dong-A Pharmaceutical Co., Ltd. Tempo Natural Tampon Regular2023-02-14
08806011635703Dong-A Pharmaceutical Co., Ltd. Tempo Natural Tampon Super2023-02-14
08806011816720Dong-A Pharmaceutical Co., Ltd.FATION NOSCA9 SPOT PATCH2023-07-05
08806011636755Dong-A Pharmaceutical Co., Ltd.Tempo Natural Cotton Liner Long2023-07-05
08806011637080Dong-A Pharmaceutical Co., Ltd. Tempo Natural Cotton Pad - M2023-07-05
08806011637097Dong-A Pharmaceutical Co., Ltd. Tempo Natural Cotton Pad - L2023-07-05
08806011637462Dong-A Pharmaceutical Co., Ltd.Tempo Natural Cotton Overnight Super Long2023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223630224curea P1curea medical GmbHNAC2026-09-27
04260223630231curea P1curea medical GmbHNAC2026-09-27
04260223630248curea P1curea medical GmbHNAC2026-09-27
04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
04260223630668curea P2curea medical GmbHNAC2026-09-27
04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
04260223630989curea P1 heelcurea medical GmbHNAC2026-09-27
04260223631184curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631191curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631207curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631214curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631368curea P1curea medical GmbHNAC2026-09-27
04260223631672curea P2curea medical GmbHNAC2026-09-27
04260223631696curea P2curea medical GmbHNAC2026-09-27
04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
04260223631795curea P2 activecurea medical GmbHNAC2026-09-27
04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
04260223631931curea P1 easy bordercurea medical GmbHNAC2026-09-27
00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04