FDA.reportPublic FDA data

Celadia

Primary DI
00850072068817
Brand
Celadia
Company
Biowound Solutions, Inc.
Model
CP001000
Published
2025-12-18
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
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
10850072068814PackageGS110In Commercial Distribution
20850072068811PackageGS140In Commercial Distribution
00850072068817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007206881410850072068814
2085007206881120850072068811
00850072068817008500720688178500720688170850072068817

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Regulatory Flags#

DUNS number
135705894
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072068565CeladiaSF100100F2025-12-18
00850072068572CeladiaSF150150F2025-12-18
00850072068589CeladiaSF175170FS2025-12-18
00850072068596CeladiaSF210210FS2025-12-18
00850072068602CeladiaSF100100N2025-12-18
00850072068619CeladiaSF150150N2025-12-18
00850072068626CeladiaSP100100A2025-12-18
00850072068633CeladiaSP150150A2025-12-18
00850072068640CeladiaSP200200A2025-12-18
00850072068657CeladiaSP1001002025-12-18
00850072068664CeladiaSP1501502025-12-18
00850072068671CeladiaSP2002002025-12-18
00850072068695CeladiaAD1501502025-12-18
00850072068701CeladiaSA100100-R2025-12-18
00850072068718CeladiaSA150150-R2025-12-18
00850072068725CeladiaSC100100S-P2025-12-18
00850072068732CeladiaSC150150S-P2025-12-18
00850072068756CeladiaSO100100H2025-12-18
00850072068763CeladiaSO150150H2025-12-18
00850072068770CeladiaSS150120-122025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31