Primary Device ID | 10389130444418 |
NIH Device Record Key | 899501ed-9f96-42e0-ae9a-262f3c748c35 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SUPARTZ FX sodium hyaluronate |
Version Model Number | 71564444 |
Company DUNS | 078450878 |
Company Name | BIOVENTUS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10389130444418 [Primary] |
GS1 | 20389130444415 [Package] Package: Outer box [5 Units] In Commercial Distribution |
GS1 | 30389130444412 [Package] Contains: 20389130444415 Package: Packing Case [36 Units] In Commercial Distribution |
GS1 | 40389130444419 [Package] Contains: 30389130444412 Package: Shipping carton [1 Units] In Commercial Distribution |
HIBCC | M717715644440 [Previous] |
MOZ | Acid, Hyaluronic, Intraarticular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-06 |
Device Publish Date | 2023-09-28 |
00816986020525 - Osteoamp Flowable Access Cannula | 2024-11-29 The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided ste |
10389130444418 - SUPARTZ FX sodium hyaluronate | 2023-10-06SUPARTZ 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). |
10389130444418 - SUPARTZ FX sodium hyaluronate | 2023-10-06 SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respon |
M937710346601 - EXOGEN Metatarsal Strap | 2021-12-27 |
00816986020488 - SIGNAFUSE Bioactive Bone Graft | 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas |
00816986020495 - SIGNAFUSE Bioactive Bone Graft | 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas |
00816986020501 - SIGNAFUSE Bioactive Bone Graft | 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas |
00816986020518 - SIGNAFUSE Bioactive Bone Graft | 2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas |
00816986020006 - SIGNAFUSE | 2020-03-20 Bioactive Bone Graft Putty |