FDA.reportPublic FDA data

Transparent Film Dressings

Primary DI
16937935325148
Brand
Transparent Film Dressings
Company
Shanghai Iso Medical Products Co., Ltd.
Model
10.2x12.1cm
Published
2023-07-27
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
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
56937935325146PrimaryGS10
16937935325148Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5693793532514656937935325146
1693793532514816937935325148

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420364846
Device count
3000
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
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
06937935328753Transparent Adhesive Film DressingTF44751002025-01-22
06937935328760Transparent Adhesive Film DressingTF86102025-01-22

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