FDA.reportPublic FDA data

RESTORE CALCICARE

Primary DI
30610075099376
Brand
RESTORE CALCICARE
Company
ADVANCED MEDICAL SOLUTIONS LIMITED
Model
RESTORE CALCICARE
Catalog number
9937
Device description
RESTORE CALCICARE 4X4IN (10X10CM) REF:9937 10/10
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610075099376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061007509937630610075099376

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.

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
15032749000197ActivHealHydrocolloid Foam Backed100090052023-05-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940113DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940120DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940137DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940175DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940199DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940243DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940250DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940267DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940274DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940281DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940298DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22