SUPARTZ® sodium hyaluronate

Basic Information

• Brand Name: SUPARTZ® sodium hyaluronate
• Primary DI: M717715655550
• Version / Model: 89130-5555-01
• Catalog Number: 7156-5555
• Company Name: SEIKAGAKU CORPORATION
• Labeler DUNS: 690584057
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 4
• Public Version Date: 2018-07-31
• Public Version Status: Update
• Public Device Record Key: 371322d8-acc6-45c8-b0bb-d894576b9a7f
• Distribution End Date: 2018-07-31

Device Description

SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOZ	Acid, Hyaluronic, Intraarticular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44757	Synovial fluid supplementation medium	A sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M717715655554	HIBCC	Shipping Carton	1	Not in Commercial Distribution	2018-07-31
Package	M717715655553	HIBCC	Packing Case	36	Not in Commercial Distribution	2018-07-31
Package	M717715655552	HIBCC	Outer Box	5	Not in Commercial Distribution	2018-07-31
Primary	M717715655550	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P980044	019
P980044	020
P980044	021
P980044	022
P980044	023
P980044	024
P980044	025

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius