FDA.reportPublic FDA data

SEIKAGAKU CORPORATION, TAKAHAGI PLANT

Matched from indexed company URL: Seikagaku Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96123921000255210SEIKAGAKU CORPORATION, TAKAHAGI PLANT1N2026-01-01258-5, AZA-MATSUKUBO OAZA-AKAHAMA TAKAHAGI-SHI Ibaraki JP 318-0001

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00087541300912Gel-One® Cross-linked Hyaluronate - 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.8003482759xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
584211348459251P980044SUPARTZ FXMOZ2001-01-24
584211661197984P080020GEL-ONEMOZ2011-03-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOZ42011-03-22

PMA#

Gel-One

2023-01-05

SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS051 Date Received12/08/2022 Decision Date01/05/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

Gel-One

2022-10-19

SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS049 Date Received09/20/2022 Decision Date10/19/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

Gel-One

2022-07-22

SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS048 Date Received06/22/2022 Decision Date07/22/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

GEL-ONE

2022-03-31

SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS047 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

Suparts FX & Visco-3

2022-03-31

SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP980044 Supplement NumberS059 Date Received03/02/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process ...

105 records. Showing 1-40. Next

PMN#

GUDID#

VISCO-3 sodium hyaluronate - VISCO-3 (P980044/S027) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.VISCO-3 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. VISCO-3 is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

SEIKAGAKU CORPORATION

2017-03-22

SUPARTZ FX sodium hyaluronate - SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

SEIKAGAKU CORPORATION

2017-01-31

Gel-One® Cross-linked Hyaluronate - 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

2020-01-15

Gel-One® Cross-linked Hyaluronate - 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

2014-09-17

SUPARTZ® sodium hyaluronate - SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

SEIKAGAKU CORPORATION

2017-01-31