FDA UDI
In Commercial Distribution
🇺🇸 United States
Caesar Pro
DI: 08055002900195
·
Model: CP18200-C0
·
MEDAX SRL UNIPERSONALE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Caesar Pro
- Primary DI
- 08055002900195
- Version / Model
- CP18200-C0
- Company Name
- MEDAX SRL UNIPERSONALE
- Labeler DUNS
- 440211428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 041bd41f-04c0-49d9-b15a-9e7f1ba654ba
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16835 | Soft-tissue biopsy procedure kit, non-medicated | A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18055002900192 | GS1 | Carton Box | 10 | In Commercial Distribution | |
| Primary | 08055002900195 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092338 | 000 |