FDA.reportPublic FDA data

ComfiTel Healogics by DermaRite

Primary DI
00714196931726
Brand
ComfiTel Healogics by DermaRite
Company
Sion Brands LLC
Model
93172
Published
2020-09-01
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714196931726PrimaryGS10
01714196931725Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196931726007141969317267141969317260714196931726
01714196931725017141969317251714196931725

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, wound-nonadherentA sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed. It may be applied directly to tissue or used in combination with other dressings (e.g., gels) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, shallow ulcers). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118753405
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714196112453DermaSyn112452020-09-01
00714196930712Bordered Foam Healogics by DermaRite930712020-09-01
00714196930736Bordered Foam Healogics by DermaRite930732020-09-01
01714196422629ComfortGauze Border422622025-01-08
01714196422636ComfortGauze Border422632025-01-08
07141964645074AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
71419624712486DermaSyn002472024-10-21
01714196500150SilvaKollagen Gel00500005002023-10-04
00714196390028AquaDerm00322E2022-05-02
00714196391780DermaFilm thin with Border00229E2021-09-10
00714196390004Adhesive Tape Remover Pads821002021-09-09
00714196390042AquaDerm00324E2021-09-09
00714196390066AquaRite Extra CMC40220402202021-09-09
00714196390080AquaRite Extra CMC40318403182021-09-09
00714196390103AquaRite Extra CMC404502021-09-09
00714196390127AquaRite Extra CMC406602021-09-09
00714196390141"Bordered Foam 4"" Round"00288E2021-09-09
00714196390165Bordered Foam00297E2021-09-09
00714196390189Bordered Foam00298E2021-09-09

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