AccessGUDID - DEVICE: TriLURON (M71389122087901A1)

GUDID

Device Identifier (DI) Information

Brand Name: TriLURON
Version or Model: M71389122087901A13
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 89122-0879-01
Company Name: FIDIA FARMACEUTICI SPA

Primary DI Number: M71389122087901A1
Issuing Agency: HIBCC
Commercial Distribution End Date: July 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 428453013 *Terms of Use

Device Description: TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL

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 [?]
P180040	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
No Device Sizes

Device Record Status

Public Device Record Key: dc996787-66d3-40d8-a3c9-0ed1eea38507
Public Version Date: July 02, 2024
Public Version Number: 2
DI Record Publish Date: November 04, 2019