AccessGUDID - DEVICE: Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe (M71389122049663A16)

GUDID

Device Identifier (DI) Information

Brand Name: Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe
Version or Model: 89122-0496-63
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 89122-0496-63
Company Name: FIDIA FARMACEUTICI SPA

Primary DI Number: M71389122049663A16
Issuing Agency: HIBCC
Commercial Distribution End Date: October 04, 2022
Device Count: 2
Labeler D-U-N-S® Number*: 428453013 *Terms of Use

Device Description: HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.

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 [?]
P150010	000

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: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 9bda49c9-219c-45e9-bf97-2c6b771ddb9f
Public Version Date: September 15, 2023
Public Version Number: 4
DI Record Publish Date: March 21, 2016