Multi-Trauma Dressing
- Primary DI
- 00616784353135
- Brand
- Multi-Trauma Dressing
- Company
- DYNAREX CORPORATION
- Model
- 3531
- Device description
- Multi-Trauma Dressing, Sterile, 10"x30"
- 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 |
|---|
| FBY | Cooler, Esophageal And Gastric |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FBY | Cooler, Esophageal And Gastric | Unknown | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00616784353135 | Package | GS1 | 50 | In Commercial Distribution |
| 00616784353111 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00616784353135 | 00616784353135 | 616784353135 | 0616784353135 |
| 00616784353111 | 00616784353111 | 616784353111 | 0616784353111 |
GMDN Terms
| Term | Definition |
|---|
| Pressure bandage, non-latex, single-use | A strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It 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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Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00616784352039 | Burn Sheet, Sterile | DYNAREX CORPORATION | FBY | 2021-06-21 |