Synvisc
GUDID 5060459970014
ALLY MEDICAL SUPPLIES LTD
Synovial fluid supplementation medium| Primary Device ID | 5060459970014 |
| NIH Device Record Key | 4976953e-dc9e-4d32-a528-1eefd33e621a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synvisc |
| Version Model Number | None |
| Company DUNS | 220744126 |
| Company Name | ALLY MEDICAL SUPPLIES LTD |
| Device Count | 3 |
| 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 |
Customer Support Contacts
| Phone | 516-206-1003 |
| jeff@allymedicalsupplies.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060459970007 [Primary] |
| GS1 | 05060459970014 [Unit of Use] |
| GS1 | 5060459970014 [Package] Contains: 05060459970007 Package: [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P940015
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 | 2018-07-06 |
| Device Publish Date | 2015-10-23 |
Devices Manufactured by ALLY MEDICAL SUPPLIES LTD
| 5060459970014 - Synvisc | 2018-07-06 |
| 5060459970014 - Synvisc | 2018-07-06 |
| 05060459970021 - Synvisc One | 2018-07-06 |
| 05060459970038 - Orthovisc | 2018-07-06 |
| 05060459970045 - Euflexxa | 2018-07-06 |
| 05060459970052 - Hyalgan | 2018-07-06 |
| 05060459970090 - Monovisc | 2018-07-06 |
| 05060459970120 - Supartz | 2018-07-06 |
Trademark Results [Synvisc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNVISC 73597580 1418125 Live/Registered |
BIOMATRIX, INC. 1986-05-08 |
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