| Primary Device ID | 00850051939398 |
| NIH Device Record Key | 81cc4df2-d0db-4ae9-be37-0c98f7d21436 |
| Commercial Distribution Discontinuation | 2030-05-18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exorb Ankle Large |
| Version Model Number | EA2350 |
| Catalog Number | ECA300 |
| Company DUNS | 609397224 |
| Company Name | SUN SCIENTIFIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com | |
| Phone | 9144795108 |
| aalward@sun-scientific.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850051939398 [Primary] |
| NAC | Dressing, Wound, Hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-08 |
| Device Publish Date | 2024-07-31 |
| 00850051939558 - Knee Compression Wrap Large | 2024-10-03 Aero-Wrap™ Knee Compression Wrap is designed to provide therapeutic compression therapy, in the inpatient and outpatient setti |
| 00850051939527 - CopperUnder sock Small/Medium | 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester small/medium |
| 00850051939534 - CopperUnder sock Large | 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Large |
| 00850051939541 - CopperUnder sock Extra Large | 2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Extra Large |
| 00850051939367 - ExuCare Scalp Large | 2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head |
| 00850051939374 - ExuCare Scalp Pediatric | 2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head |
| 00850051939381 - ExuCare Large with foot | 2024-08-08 A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury t |
| 00850051939398 - Exorb Ankle Large | 2024-08-08A wound cover that wraps around the ankle which is intended to be used as an initial, short-term treatment after injury that consists of an high drainage absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device. |
| 00850051939398 - Exorb Ankle Large | 2024-08-08 A wound cover that wraps around the ankle which is intended to be used as an initial, short-term treatment after injury that con |