FDA.reportPublic FDA data

Rotium

Primary DI
00852513007461
Brand
Rotium
Company
NANOFIBER SOLUTIONS, INC.
Model
FG-0430
Published
2025-04-17
Public version status
Update
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
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852513007461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852513007461008525130074618525130074610852513007461

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830384223
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852513007058Rotium Bioresorbable WickFG-00072019-04-03
00852513007447RotiumFG-02202025-04-17
00852513007454RotiumFG-03252025-04-17
00852513007478RotiumFG-05252025-04-17
00852513007485RotiumFG-06302025-04-17
00852513007492RotiumFG-07252025-04-17
00852513007317Rotium Bioresorbable WickFG-00432022-10-18
00852513007393Phoenix Surgical Wound Matrix FenestratedFG-00532025-04-17
00852513007409Phoenix Surgical Wound Matrix FenestratedFG-00542025-04-17
00852513007416Phoenix Surgical Wound Matrix FenestratedFG-00552025-04-17
00852513007423Phoenix Surgical Wound Matrix FenestratedFG-00562025-04-17
00852513007430Phoenix Surgical Wound Matrix FenestratedFG-00572025-04-17
00852513007362ElectroFiber 3D MatrixFG-0061EF3D-10202024-11-14
00852513007379ElectroFiber 3D MatrixFG-0062EF3D-10102024-11-14
00852513007386ElectroFiber 3D MatrixFG-0063EF3D-05052024-11-14
00852513007355BIOCHARGEFG-2012BC-20122024-09-25
00852513007331Rotium RCO Bioresorbable WickFG-10232024-01-09
00852513007348Rotium RCO Bioresorbable WickFG-10432024-01-09
00852513007003Phoenix Surgical Wound Matrix FenestratedFG-0051FG-00512023-02-16
00852513007324Phoenix Surgical Wound Matrix FenestratedFG-0052FG-00522023-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-12-21
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-11-21
20653405990700BioBraceConmed CorporationOWW2025-10-28
30653405990707BioBraceConmed CorporationOWW2025-10-28
06975222391004SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391011SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391028SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391035SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391042SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391059SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391066SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391073SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391080SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391097SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391103SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391110SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391127SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391134SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391141SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391158SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391165SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391172SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391189SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391196SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
00852513007447RotiumNANOFIBER SOLUTIONS, INC.OWW2025-04-17
00852513007454RotiumNANOFIBER SOLUTIONS, INC.OWW2025-04-17
00852513007478RotiumNANOFIBER SOLUTIONS, INC.OWW2025-04-17
00852513007485RotiumNANOFIBER SOLUTIONS, INC.OWW2025-04-17
00852513007492RotiumNANOFIBER SOLUTIONS, INC.OWW2025-04-17
20653405990205BioBrace® RC Delivery SystemConmed CorporationOWW2025-04-11