FDA.report

DynaGuard Waterproof Composite Dressing

Primary DI
00616784303628
Brand
DynaGuard Waterproof Composite Dressing
Company
DYNAREX CORPORATION
Model
3036
Device description
DynaGuard Waterproof Composite Dressing, Bordered, 6"x6"
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
00616784303628PackageGS110In Commercial Distribution
00616784303635PackageGS112In Commercial Distribution
00616784303611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784303628006167843036286167843036280616784303628
00616784303635006167843036356167843036350616784303635
00616784303611006167843036116167843036110616784303611

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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