FDA.reportPublic FDA data

Cealogic Ribbon

Primary DI
00861092002637
Brand
Cealogic Ribbon
Company
RECIBIO, INC.
Model
9356
Device description
Advanced support matrix for enhanced closure integrity
Published
2026-03-01
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143124000KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.2015-01-26KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861092002634PackageGS110In Commercial Distribution
20861092002631PackageGS110In Commercial Distribution
00861092002637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086109200263410861092002634
2086109200263120861092002631
00861092002637008610920026378610920026370861092002637

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-8447324246customercare@recibio.us

Regulatory Flags#

DUNS number
081273312
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861092002606CeaLogic Ratio Applicator Kit31012026-03-01
00861092002644Cealogic Film93572026-03-01
00861092002613CeaLogic Specimen Collection Kit27012026-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008106599NeoMatriX Wound MatrixNEXTGEN BIOLOGICS INCKGN2026-10-21
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