FDA.reportPublic FDA data

ActivHeal

Primary DI
15032749000197
Brand
ActivHeal
Company
ADVANCED MEDICAL SOLUTIONS LIMITED
Model
Hydrocolloid Foam Backed
Catalog number
10009005
Device description
Hydrocolloid Foam Backed Dressing SACRAL
Published
2023-05-05
Public version status
Update
Distribution status
Not 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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15032749000197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1503274900019715032749000197

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
770434090
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15032749000098ActivHealHydrocolloid Film Backed100086312023-05-05
15032749000104ActivHealHydrocolloid Film Backed100085282023-05-05
15032749000128ActivHealHydrocolloid Film Backed100085302023-05-05
15032749000166ActivHealHydrocolloid Foam Backed10009002 2023-05-05
15032749000173ActivHealHydrocolloid Foam Backed100090032023-05-05
15032749000180ActivHealHydrocolloid Foam Backed100090042023-05-05
10612479250380McKesson Moisture Wicking Fabric Ag 16-10144R2022-12-08
10612479250403McKesson Moisture Wicking Fabric Ag 16-1036S2022-12-08
07332551227340MelgisorbAg Alginate2551502022-12-08
07332551227357MelgisorbAg Alginate2551002022-12-08
07332551227364MelgisorbAg Alginate2550502022-12-08
07332551242831MelgisorbAg Alginate2552002022-12-08
07332551992040MelgisorbAg Alginate2556002022-12-08
05032749040851MelgisorbAg Alginate2550502025-04-14
05032749040882MelgisorbAg Alginate2551002025-04-14
05032749040912MelgisorbAg Alginate2551502025-04-14
05032749040943MelgisorbAg Alginate2552002025-04-14
05032749040974MelgisorbAg Alginate2556002025-04-14
15032749039166Actibride™Debridement Pad90391692024-08-30
25032749041128ActivHealNON ADHESIVE FOAM TRILAM90411242025-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
10840330701591ProCureTwin Med, LLCNAD2026-04-28
10840330701607ProCureTwin Med, LLCNAD2026-04-28
10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21
10192253038828KendallCardinal Health 200, LLCNAD2025-11-21
10192253038866KendallCardinal Health 200, LLCNAD2025-11-21
10197344169559MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-14
10197344162512MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169344MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169351MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169368MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07
10197344169375MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-11-07