DEVICE: Gel-One® Cross-linked Hyaluronate (00087541300912)

Device Identifier (DI) Information

Gel-One® Cross-linked Hyaluronate
00-1111-001-00
In Commercial Distribution
00-1111-001-00
SEIKAGAKU CORPORATION
00087541300912
GS1

1
690584057 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
MOZ Acid, Hyaluronic, Intraarticular
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FDA Premarket Submission

FDA Premarket 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
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4aae65b2-5381-4f58-976e-3f5f1bf2aee8
July 06, 2018
3
September 17, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8003482759
xxx@xxx.xxx
5743724999
xxx@xxx.xxx
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