FDA.report

DynaGuard Waterproof Composite Dressing

Primary DI
00616784303529
Brand
DynaGuard Waterproof Composite Dressing
Company
DYNAREX CORPORATION
Model
3035
Device description
DynaGuard Waterproof Composite Dressing, 4"x4"
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
NACDressing, Wound, Hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784303529PackageGS110In Commercial Distribution
00616784303536PackageGS112In Commercial Distribution
00616784303512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784303529006167843035296167843035290616784303529
00616784303536006167843035366167843035360616784303536
00616784303512006167843035126167843035120616784303512

GMDN Terms

TermDefinition
Surgical anti-adhesion material, nonimplantableA material intended to be placed in the body short term (<= 30 days) to prevent the abnormal fibrous union (adhesion) between one body part/tissue to another, or between one body part/tissue and a dressing, following a surgical procedure. It is made of a single or composite polymer (e.g., hydrogel, silicone) in the form of a barrier membrane or fluid dressing, and may be cut to a desired size/shape. This is a single-use 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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