FDA UDI
In Commercial Distribution
🇺🇸 United States
CONVERTORS
DI: 10885380137587
·
Model: 29456
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CONVERTORS
- Primary DI
- 10885380137587
- Version / Model
- 29456
- Catalog Number
- 29456
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-28
- Public Version
- 3
- Public Version Date
- 2018-07-19
- Public Version Status
- Update
- Public Device Record Key
- cb8b3d12-c888-4280-b63d-471099f20762
Device Description
Angiography Drape
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
- Yes
- 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 |
|---|---|---|---|---|
| 16006 | Angiographic drape | A flexible, protective covering made of natural or synthetic materials, or both, designed to be used on patients during an angiographic procedure to control microbial and substance (e.g., blood, contrast material) contamination of the patient entry field. It may be specific for brachial or femoral procedures, and may include a window(s) for viewing and/or a trough to collect spilled substances. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380137585 | GS1 | CASE | 14 | In Commercial Distribution | |
| Primary | 10885380137587 | GS1 |