FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardinal Health™ Surgical Incise Drape with CHG
DI: 00817138014997
·
Model: 60x 85 cm
·
AVERY DENNISON CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Basic Information
- Brand Name
- Cardinal Health™ Surgical Incise Drape with CHG
- Primary DI
- 00817138014997
- Version / Model
- 60x 85 cm
- Catalog Number
- 9379
- Company Name
- AVERY DENNISON CORPORATION
- Labeler DUNS
- 008256364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2023-06-21
- Public Version
- 1
- Public Version Date
- 2023-06-29
- Public Version Status
- New
- Public Device Record Key
- c7b1c26f-cc5e-447b-ae46-01851ad8a086
Device Description
Surgical Drape
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10817138014994 | GS1 | ||||
| Primary | 00817138014997 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 85 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No direct sunlight