AccessGUDID - DEVICE: SUPARTZ® sodium hyaluronate (M717715655550)

GUDID

Device Identifier (DI) Information

Brand Name: SUPARTZ® sodium hyaluronate
Version or Model: 89130-5555-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7156-5555
Company Name: SEIKAGAKU CORPORATION

Primary DI Number: M717715655550
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 690584057 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MOZ	Acid, Hyaluronic, Intraarticular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980044	019
P980044	020
P980044	021
P980044	022
P980044	023
P980044	024
P980044	025

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 371322d8-acc6-45c8-b0bb-d894576b9a7f
Public Version Date: July 31, 2018
Public Version Number: 4
DI Record Publish Date: January 31, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M717715655554	1	M717715655553	2018-07-31	Not in Commercial Distribution	Shipping Carton
M717715655553	36	M717715655552	2018-07-31	Not in Commercial Distribution	Packing Case
M717715655552	5	M717715655550	2018-07-31	Not in Commercial Distribution	Outer Box