FDA.report

SiliGentle Silicone Bordered Foam Dressing

Primary DI
00616784306322
Brand
SiliGentle Silicone Bordered Foam Dressing
Company
DYNAREX CORPORATION
Model
3063
Device description
SiliGentle Silicone Bordered Foam Dressing, Large Sacral,9"x9"
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784306322PackageGS15In Commercial Distribution
00616784306339PackageGS112In Commercial Distribution
00616784306315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784306322006167843063226167843063220616784306322
00616784306339006167843063396167843063390616784306339
00616784306315006167843063156167843063150616784306315

GMDN Terms

TermDefinition
Pressure-management bandage, siliconeA non-sterile piece of silicone material intended to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility. It is available in various shapes (e.g.,, concave shapes for the heel or elbow, pads for the sacrum, and sheets or strips for other areas of the body) and sizes, and may be used in a healthcare facility or in the home. This is a single-patient, reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
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
true
Sterilization required before use
false

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