FDA.reportPublic FDA data

Transparent Adhesive Film Dressing

Primary DI
06937935328753
Brand
Transparent Adhesive Film Dressing
Company
Shanghai Iso Medical Products Co., Ltd.
Model
TF4475100
Device description
PU Dressing without Pad 10x12cm
Published
2025-01-22
Public version status
New
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
36937935328754PackageGS1100In Commercial Distribution
46937935328751PackageGS15In Commercial Distribution
56937935328758PackageGS12In Commercial Distribution
06937935328753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3693793532875436937935328754
4693793532875146937935328751
5693793532875856937935328758
06937935328753069379353287536937935328753

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA 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 covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.

Regulatory Flags#

DUNS number
420364846
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937935319003Silicone Foam Dressing with Adhesive Border46-9222025-10-29
06937935319010Silicone Foam Dressing with Adhesive Border46-9332025-10-29
06937935319027Silicone Foam Dressing with Adhesive Border46-9442025-10-29
06937935319034Silicone Foam Dressing with Adhesive Border46-9662025-10-29
06937935319041Silicone Foam Dressing with Adhesive Border46-94102025-10-29
06937935319058Silicone Foam Sacral Dressing with Adhesive Border46-9772025-10-29
06937935319065Silicone Foam Sacral Dressing with Adhesive Border46-9992025-10-29
06937935319072Silicone Foam Heel Dressing with Adhesive Border46-9792025-10-29
06937935319089Silicone Foam Dressing46-944N2025-10-29
06937935319096Silicone Foam Dressing46-966N2025-10-29
06937935319102Silicone Foam Oval Dressing with Adhesive Border46-9242025-10-29
06937935319119Silicone Foam Dressing with Adhesive Border46-922L2025-10-29
06937935319126Silicone Foam Dressing with Adhesive Border46-944L2025-10-29
06937935319133Silicone Foam Dressing with Adhesive Border46-966L2025-10-29
06937935328715Transparent Adhesive Film DressingTF22502025-01-22
06937935328722Transparent Adhesive Film DressingTF221002025-01-22
06937935328739Transparent Adhesive Film DressingTF4475202025-01-22
06937935328746Transparent Adhesive Film DressingTF4475502025-01-22
06937935328760Transparent Adhesive Film DressingTF86102025-01-22
06937935328777Transparent Adhesive Film DressingTF86202025-01-22

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