FDA.reportPublic FDA data

Celadia

Primary DI
00850072068626
Brand
Celadia
Company
Biowound Solutions, Inc.
Model
SP100100A
Device description
Collagen Wound Dressing
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
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
10850072068623PackageGS125In Commercial Distribution
20850072068620PackageGS112In Commercial Distribution
00850072068626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007206862310850072068623
2085007206862020850072068620
00850072068626008500720686268500720686260850072068626

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Regulatory Flags#

DUNS number
135705894
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
00850072068565CeladiaSF100100F2025-12-18
00850072068572CeladiaSF150150F2025-12-18
00850072068589CeladiaSF175170FS2025-12-18
00850072068596CeladiaSF210210FS2025-12-18
00850072068602CeladiaSF100100N2025-12-18
00850072068619CeladiaSF150150N2025-12-18
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
00850072068787CeladiaSS074044O-182025-12-18

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