FDA UDI
In Commercial Distribution
🇺🇸 United States
Dealmed
DI: 00817415022264
·
Model: 783410
·
DEALMED MEDICAL SUPPLIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dealmed
- Primary DI
- 00817415022264
- Version / Model
- 783410
- Catalog Number
- 783410
- Company Name
- DEALMED MEDICAL SUPPLIES LLC
- Labeler DUNS
- 068586441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-29
- Public Version
- 1
- Public Version Date
- 2022-09-06
- Public Version Status
- New
- Public Device Record Key
- 73ed2672-81ed-4e74-8d98-23b6a8e266ce
Device Description
18" x 26" Non Fenestrated Drape Ea
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUI | Drape, Surgical, Exempt | 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 | 10817415022261 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00817415022264 | GS1 | ||||
| Package | 20817415022268 | GS1 | Case | 6 | In Commercial Distribution |