FDA UDI
In Commercial Distribution
🇺🇸 United States
NEXA Drape
DI: 25060826400056
·
Model: 414-00-601
·
NEXA MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NEXA Drape
- Primary DI
- 25060826400056
- Version / Model
- 414-00-601
- Company Name
- NEXA MEDICAL LIMITED
- Labeler DUNS
- 221046947
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-30
- Public Version
- 1
- Public Version Date
- 2023-09-07
- Public Version Status
- New
- Public Device Record Key
- 496e8a0c-a601-4888-9bf0-54f94ec3f6ca
Device Description
Single drape pieces
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47405 | Negative-pressure wound therapy system drape | A sheet of plastic material designed to be placed over a wound dressing (e.g. open-cell foam or medicated gauze) to create a complete occlusion over and around a wound during negative pressure wound therapy (NPWT). This film dressing is typically vapour permeable, waterproof, and has an adhesive backing or edges applied against the wound dressing and surrounding healthy skin to create an airtight seal; it may be impregnated/coated with a gel (e.g., silicone) to minimize risk of trauma upon removal. It has a central opening, or an opening is made in or under it, to enable placement of the drain allowing negative pressure to reach the wound through the dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15060826400059 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 25060826400056 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162610 | 000 |