FDA.reportPublic FDA data

DynaGinate AG Silver Calcium Alginate Rope Dressing

Primary DI
00616784303314
Brand
DynaGinate AG Silver Calcium Alginate Rope Dressing
Company
Dynarex Corporation
Model
3033
Device description
"DynaGinate AG Silver Calcium Alginate Rope Dressing, 12"" (30cm), High Absorbency, For Wound Stages 3,4"
Published
2022-04-25
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784303321PackageGS15In Commercial Distribution
00616784303338PackageGS110In Commercial Distribution
00616784303314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784303321006167843033216167843033210616784303321
00616784303338006167843033386167843033380616784303338
00616784303314006167843033146167843033140616784303314

GMDN Terms#

Term, Definition table
TermDefinition
Cavity-wound management dressing, antimicrobialA non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent), and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01
00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29