AccessGUDID - DEVICE: Hyalgan® Sodium Hylauronate Pre-filled Syringe

GUDID

Device Identifier (DI) Information

Brand Name: Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
Version or Model: 89122-0724-20
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 89122-0724-20
Company Name: FIDIA FARMACEUTICI SPA

Primary DI Number: M71389122072420A1
Issuing Agency: HIBCC
Commercial Distribution End Date: September 19, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 428453013 *Terms of Use

Device Description: Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

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

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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 [?]
P950027	006

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
Special Storage Condition, Specify: Store in original packaging (protected from light)
Special Storage Condition, Specify: Store Below 77°F
Special Storage Condition, Specify: Do Not Freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddad4099-2f1d-470f-b65a-af8738f6baeb
Public Version Date: July 01, 2024
Public Version Number: 5
DI Record Publish Date: July 31, 2015