GELSYN-3
GUDID 08033638951057
INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT
IBSA FARMACEUTICI ITALIA SRL
Synovial fluid supplementation medium| Primary Device ID | 08033638951057 |
| NIH Device Record Key | 7f58a728-9b07-450d-a1b7-ee034f77e9c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GELSYN-3 |
| Version Model Number | GS3111 |
| Company DUNS | 655395317 |
| Company Name | IBSA FARMACEUTICI ITALIA SRL |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it | |
| Phone | 1-800-836-4080 |
| info@ibsa.it |
Device Dimensions
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
| Total Volume | 2.25 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *NO FREEZE |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033638951057 [Primary] |
| NDC/NHRIC | 89130-3111-1 [Secondary] |
FDA Product Code
| MOZ | Acid, Hyaluronic, Intraarticular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-02-22 |
| Device Publish Date | 2016-07-25 |
Trademark Results [GELSYN-3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELSYN-3 86888721 5125702 Live/Registered |
BIOVENTUS LLC 2016-01-27 |
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