DUROLANE 1082020

GUDID 00816986020808

DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.

BIOVENTUS LLC

Synovial fluid supplementation medium
Primary Device ID00816986020808
NIH Device Record Key0568a2f4-3e60-4c2f-9f28-d40c3695327d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUROLANE
Version Model Number1082020
Catalog Number1082020
Company DUNS078450878
Company NameBIOVENTUS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-836-4080
EmailcustomerserviceUSA@bioventusglobal.com
Phone800-836-4080
EmailcustomerserviceUSA@bioventusglobal.com
Phone800-836-4080
EmailcustomerserviceUSA@bioventusglobal.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816986020808 [Primary]
GS110816986020805 [Package]
Package: Case [54 Units]
In Commercial Distribution
NDC/NHRIC89130-2020-1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOZAcid, Hyaluronic, Intraarticular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-20

Devices Manufactured by BIOVENTUS LLC

10389130444418 - SUPARTZ FX sodium hyaluronate2023-10-06 SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respon
M937710346601 - EXOGEN Metatarsal Strap2021-12-27
00816986020488 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020495 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020501 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020518 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020006 - SIGNAFUSE2020-03-20 Bioactive Bone Graft Putty
00816986020013 - SIGNAFUSE2020-03-20 Bioactive Bone Graft Putty

Trademark Results [DUROLANE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DUROLANE
DUROLANE
86950374 5196963 Live/Registered
Bioventus LLC
2016-03-23
DUROLANE
DUROLANE
77781493 3762687 Dead/Cancelled
BIOVENTUS LLC
2009-07-15
DUROLANE
DUROLANE
76119661 2753628 Dead/Cancelled
Q-MED AB
2000-08-29
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