| Primary Device ID | 00852181005332 |
| NIH Device Record Key | c7737a1c-ab23-4006-9bb4-94ecab7012ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Catasyn (3oz) |
| Version Model Number | 3 oz |
| Company DUNS | 830276353 |
| Company Name | SYNEDGEN, INC. |
| 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 | true |
| 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 | true |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com | |
| Phone | 855-774-7962 |
| info@Synedgen.com |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Total Volume | 3 Fluid Ounce |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852181005332 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-09 |
| Device Publish Date | 2021-03-01 |
| 00852181005332 - Catasyn (3oz) | 2021-03-09Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin. Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns. |
| 00852181005332 - Catasyn (3oz) | 2021-03-09 Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and min |
| 00852181005097 - Moisyn Dry Mouth Oral Rinse | 2020-12-30 Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolym |
| 00852181005134 - Moisyn Dry Mouth Oral Mist | 2020-12-30 Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolym |
| 00852181005141 - Moisyn Dry Mouth Oral Rinse | 2020-12-30 |
| 00852181005295 - SynePure Wound Cleanser | 2020-10-09 SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, di |
| 00852181005301 - SynePure Wound Cleanser | 2020-10-09 SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, di |
| 00852181005042 - Moisyn Dry Mouth Oral Rinse | 2020-09-30 Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolym |
| 00852181005059 - Moisyn Dry Mouth Oral Mist | 2020-09-30 Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers |