FDA.reportPublic FDA data

Rotium Bioresorbable Wick

Primary DI
00852513007058
Brand
Rotium Bioresorbable Wick
Company
NANOFIBER SOLUTIONS, INC.
Model
FG-0007
Published
2019-04-03
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

Product Codes#

Code, Name table
CodeName
MAIFastener, Fixation, Biodegradable, Soft Tissue
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852513007055PackageGS11In Commercial Distribution
20852513007052PackageGS15In Commercial Distribution
00852513007058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085251300705510852513007055
2085251300705220852513007052
00852513007058008525130070588525130070580852513007058

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Centimeter
Width2Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius

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
00852513007447RotiumFG-02202025-04-17
00852513007454RotiumFG-03252025-04-17
00852513007461RotiumFG-04302025-04-17
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

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