FDA.reportPublic FDA data

Rotium Bioresorbable Wick

Primary DI
20852513007052
Brand
Rotium Bioresorbable Wick
Company
NANOFIBER SOLUTIONS, INC.
Model
FG-0007
Published
2019-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183236000Rotium Bioresorbable WickNanofiber Solutions, LLC2019-03-11MAI

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830384223
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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