DynaGinate Calcium Alginate Dressing
- Primary DI
- 00616784302829
- Brand
- DynaGinate Calcium Alginate Dressing
- Company
- DYNAREX CORPORATION
- Model
- 3028
- Device description
- DynaGinate Calcium Alginate Dressing, 4"x8"
- Published
- 2021-06-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| NAC | Dressing, Wound, Hydrophilic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784302829 | Package | GS1 | 5 | In Commercial Distribution |
| 00616784302836 | Package | GS1 | 12 | In Commercial Distribution |
| 00616784302812 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00616784302829 | 00616784302829 | 616784302829 | 0616784302829 |
| 00616784302836 | 00616784302836 | 616784302836 | 0616784302836 |
| 00616784302812 | 00616784302812 | 616784302812 | 0616784302812 |
GMDN Terms
| Term | Definition |
|---|
| Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial | A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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