FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CONVERTORS
DI: 00885380034339
·
Model: 8145W
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CONVERTORS
- Primary DI
- 00885380034339
- Version / Model
- 8145W
- Catalog Number
- 8145W
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-09
- Public Version
- 4
- Public Version Date
- 2022-09-01
- Public Version Status
- Update
- Public Device Record Key
- c353e7de-6151-4bf7-8fad-e5c9ebae63af
- Distribution End Date
- 2022-09-01
Device Description
BACK TABLE COVER 44X75 LL 22/CS
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 |
|---|---|---|---|---|
| PUI | Drape, surgical, exempt | 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 | 00885380034339 | GS1 | ||||
| Package | 50885380034334 | GS1 | CASE | 22 | Not in Commercial Distribution | 2022-09-01 |