FDA.reportPublic FDA data

NuForra Surgical Wound Care

Primary DI
00860014518300
Brand
NuForra Surgical Wound Care
Company
KAIROS BIOSCIENCES LLC
Model
NUF-300
Device description
NuForra Surgical Wound Care consists of fibrous, Type I bovine collagen intended for the management of surgical wounds and a wide range of acute and chronic wounds. NuForra is designed to support a moist wound environment to promote natural healing.Indications for Use:Indicated for surgical wounds, partial- and full-thickness wounds, pressure ulcers (Stages I-IV), venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis ulcers, diabetic ulcers, first- and second-degree burns, cuts, and abrasions. NuForra is suitable for application to surgical incision sites and wounds.
Published
2025-08-14
Public version status
New
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
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014518300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014518300008600145183008600145183000860014518300

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3852226255contact@kairosbiosciences.com

Regulatory Flags#

DUNS number
132083159
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014518331PurForm AMPHM-1352026-10-07
00860014518348PurForm AMPHM-0882026-10-07
00860014518324PurForm AMPHM-1252025-11-20
00860014518317PurForm AMPHM-1152025-11-20
10860014518321PurForm AMPHM-1252025-11-20
00198715991772NuForraNUF-3002025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09421908222522Symphony™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222553Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222560Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222577Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222584Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222591Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222607Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222614Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222621Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222638Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222645Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222652Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222669Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222683Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222690Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222706Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
00810226442979Vive CareVIVE HEALTH LLCKGN2026-10-14
00850083365035LaviorLavior Pharma Inc.KGN2026-10-08
00850083365042LaviorLavior Pharma Inc.KGN2026-10-08
00850083365059LaviorLavior Pharma Inc.KGN2026-10-08
00850065122236VitaleCELLERA LLCKGN2026-10-01
00850088144963CARBOUNingbo kehu Medical Technology Co.,Ltd.KGN2026-09-30
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18