Gel-One® Cross-linked Hyaluronate 00-1111-001-00

GUDID 04987541300911

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.

SEIKAGAKU CORPORATION

Synovial fluid supplementation medium
Primary Device ID04987541300911
NIH Device Record Keyfe177b2d-8b74-4efd-b3a5-24e18a158a1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGel-One® Cross-linked Hyaluronate
Version Model Number00-1111-001-00
Catalog Number00-1111-001-00
Company DUNS690584057
Company NameSEIKAGAKU CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
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Device Identifiers

Device Issuing AgencyDevice ID
GS104987541300911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOZAcid, Hyaluronic, Intraarticular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-20
Device Publish Date2020-01-15

On-Brand Devices [Gel-One® Cross-linked Hyaluronate]

00087541300912Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in os
04987541300911Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in os

Trademark Results [Gel-One]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GEL-ONE
GEL-ONE
87384987 5462006 Live/Registered
SEIKAGAKU KOGYO KABUSHIKI KAISHA
2017-03-24
GEL-ONE
GEL-ONE
77181799 3687961 Live/Registered
Seikagaku Kogyo Kabushiki Kaisha
2007-05-15

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