FDA UDI
In Commercial Distribution
🇺🇸 United States
C-Core Drape, Sheet, SMS 40"x63"
DI: 00852205007700
·
Model: E201301
·
EXACT MEDICAL MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- C-Core Drape, Sheet, SMS 40"x63"
- Primary DI
- 00852205007700
- Version / Model
- E201301
- Catalog Number
- E201301
- Company Name
- EXACT MEDICAL MANUFACTURING, INC.
- Labeler DUNS
- 014464314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 6
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 1c9c3ea2-74d0-44c1-9c2c-642d3a1cd85f
Device Description
Drape, Sheet, 2Ply, 40"x63"
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 | 10852205007707 | GS1 | case | 60 | In Commercial Distribution | |
| Primary | 00852205007700 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101598 | 000 |