AccessGUDID - DEVICE: VISCO-3 sodium hyaluronate (04987541301314)

GUDID

Device Identifier (DI) Information

Brand Name: VISCO-3 sodium hyaluronate
Version or Model: 00-1111-001-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-1111-001-03
Company Name: SEIKAGAKU CORPORATION

Primary DI Number: 04987541301314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690584057 *Terms of Use

Device Description: VISCO-3 (P980044/S027) 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. VISCO-3 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 chicken 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. VISCO-3 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	027
P980044	028
P980044	032
P980044	033
P980044	034
P980044	035
P980044	036
P980044	037
P980044	038
P980044	040
P980044	041
P980044	042
P980044	043
P980044	045
P980044	046
P980044	047
P980044	048
P980044	049
P980044	050
P980044	051
P980044	053
P980044	054
P980044	055
P980044	056
P980044	057
P980044	058
P980044	059
P980044	062

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: 9b69a0b2-e472-49c8-a297-9c0057880566
Public Version Date: August 05, 2024
Public Version Number: 12
DI Record Publish Date: March 22, 2017