FDA.reportPublic FDA data

DynaGinate AG Silver Calcium Alginate Dressing

Primary DI
00616784303017
Brand
DynaGinate AG Silver Calcium Alginate Dressing
Company
Dynarex Corporation
Model
3030
Device description
"DynaGinate AG Silver Calcium Alginate Dressing, Sterile, 2"" x 2"" (5cm x 5cm), High Absorbency, For Wound Stages 3,4"
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784303024PackageGS110In Commercial Distribution
00616784303031PackageGS110In Commercial Distribution
00616784303048PackageGS16In Commercial Distribution
00616784303017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784303024006167843030246167843030240616784303024
00616784303031006167843030316167843030310616784303031
00616784303048006167843030486167843030480616784303048
00616784303017006167843030176167843030170616784303017

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair lap trayA device designed as a flat or shallow board or vessel that is attached to a wheelchair and placed across the lap of the occupant to serve as a platform for the performance of routine activities (e.g., eating, working or carrying objects).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible Bucket10372C2026-10-23
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00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
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00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30

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