FDA.reportPublic FDA data

Rotium RCO Bioresorbable Wick

Primary DI
00852513007331
Brand
Rotium RCO Bioresorbable Wick
Company
NANOFIBER SOLUTIONS, INC.
Model
FG-1023
Published
2024-01-09
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
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852513007331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852513007331008525130073318525130073310852513007331

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).

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
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
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
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07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01
07613327662016KNOTILUS+STRYKER CORPORATIONMAI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
10886705033317GRYPHON XMedos International SàrlMAI2025-04-22
10886705001040LUPINEDEPUY MITEK, LLCMAI2025-03-04
10886705023868HEALIX TRANSTENDMedos International SàrlMAI2025-03-04
07613327547429DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547436DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547443DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547450DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547467DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
10845854045794CROSSFT, HI-FIConmed CorporationMAI2024-04-18
20653405988646Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988653ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988660ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988677Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988684ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988691ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHMAI2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12