FDA.reportPublic FDA data

CARDINAL HEALTH ESSENTIALS

Primary DI
00885380108290
Brand
CARDINAL HEALTH ESSENTIALS
Company
RGH ENTERPRISES
Model
ZSCA18RRF
Catalog number
ZSCA18RRF
Device description
Reinforced Silver Calcium Alginate/CMC Dressing; Reinforced Rope; 0.75 x 18 in.
Published
2019-04-26
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

Contact Domains#

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
20885380108294PackageGS15In Commercial Distribution
50885380108295PackageGS110In Commercial Distribution
00885380108290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088538010829420885380108294
5088538010829550885380108295
00885380108290008853801082908853801082900885380108290

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Width0.75Inch

Contacts#

Phone, Email table
PhoneEmail
+1(800)409-2848xxx@xxx.xxx

Regulatory Flags#

DUNS number
049735438
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888499000523RELIAMEDZGB235ZGB2352019-05-17
00888499000530RELIAMEDZGB410ZGB4102019-05-17
00888499000547RELIAMEDZGB414ZGB4142019-05-17
00888499000561RELIAMEDZGB44ZGB442019-05-17
00888499000578RELIAMEDZGB46ZGB462019-05-17
00888499000585RELIAMEDZGB48ZGB482019-05-17
00888499000592RELIAMEDZGB66ZGB662019-05-17
00888499000608RELIAMEDZGC44ZGC442019-05-17
00888499000615RELIAMEDZGC66ZGC662019-05-20
00888499000622RELIAMEDZGFB44ZGFB442019-05-17
10885380122712CARDINAL HEALTH ESSENTIALSZTDR02ZTDR022019-05-22
10885380122729CARDINAL HEALTH ESSENTIALSZTDR04ZTDR042019-05-22
10885380122736CARDINAL HEALTH ESSENTIALSZTDR06ZTDR062019-05-22
00885380122548CARDINAL HEALTH ESSENTIALSZTSC08ZTSC082019-04-22
00885380122555CARDINAL HEALTH ESSENTIALSZTPA05AZTPA05A2019-05-22
00885380122562CARDINAL HEALTH ESSENTIALSZTPL05AZTPL05A2019-05-22
00885380122579CARDINAL HEALTH ESSENTIALSZTCL05AZTCL05A2019-05-22
00885380122685CARDINAL HEALTH ESSENTIALSZTCL01AZTCL01A2019-05-22
00885380122692CARDINAL HEALTH ESSENTIALSZTCL02AZTCL02A2019-05-22
00885380122708CARDINAL HEALTH ESSENTIALSZTCL03AZTCL03A2019-05-22

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Primary DI, Brand, Company table
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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
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00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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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