FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro Advantage
DI: M220N2071050
·
Model: N207105
·
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Pro Advantage
- Primary DI
- M220N2071050
- Version / Model
- N207105
- Catalog Number
- N207105
- Company Name
- NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Labeler DUNS
- 009831413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 5
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 3b710f9d-a345-4ef7-8e8e-2c3fee0fd5ce
Device Description
Pro Advantage Disposable Fenestrate 18x26 Polyinterlined LF 50/BX 6BX/CS
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
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47783 | Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M220N2071055 | HIBCC | Case | 300 | ||
| Package | M220N2071053 | HIBCC | Box | 50 | ||
| Primary | M220N2071050 | HIBCC |
Customer Contacts
- Phone
- 6153663225
- [email protected]