FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04961333244201
·
Model: PV-BBVC/12
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 04961333244201
- Version / Model
- PV-BBVC/12
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-15
- Public Version
- 1
- Public Version Date
- 2018-04-16
- Public Version Status
- New
- Public Device Record Key
- 35c5f103-da79-4da4-925b-f7b37b7d5426
Device Description
CBL,BNC-BNC,12 VIDEO
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17175 | Radiology information system | A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333244201 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12.0 | Feet |