Gel-One® Cross-linked Hyaluronate

Basic Information

• Brand Name: Gel-One® Cross-linked Hyaluronate
• Primary DI: 00087541300912
• Version / Model: 00-1111-001-00
• Catalog Number: 00-1111-001-00
• Company Name: SEIKAGAKU CORPORATION
• Labeler DUNS: 690584057
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-17
• Public Version: 11
• Public Version Date: 2021-03-22
• Public Version Status: Update
• Public Device Record Key: 4aae65b2-5381-4f58-976e-3f5f1bf2aee8
• Distribution End Date: 2021-01-05

Device Description

Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOZ	Acid, Hyaluronic, Intraarticular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00087541300912	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P080020	012
P080020	013
P080020	014
P080020	015
P080020	016
P080020	017
P080020	018
P080020	019
P080020	020
P080020	021
P080020	022
P080020	023
P080020	024
P080020	025
P080020	027
P080020	028
P080020	029
P080020	030
P080020	031
P080020	032
P080020	033
P080020	035
P080020	036
P080020	037
P080020	038
P080020	039
P080020	040

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius