FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 50885380054530
·
Model: 44028TNS
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 50885380054530
- Version / Model
- 44028TNS
- Catalog Number
- 44028TNS
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-06-23
- Public Version
- 6
- Public Version Date
- 2021-05-04
- Public Version Status
- Update
- Public Device Record Key
- c2f98f4b-9dcb-4f80-85f8-ea4b756409af
- Distribution End Date
- 2021-05-04
Device Description
Bilateral Knee Drape BNS
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 47782 | Patient surgical drape, single-use, non-sterile | A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 50885380054530 | GS1 | ||||
| Unit of Use | 10885380054532 | GS1 |