N/A
- Primary DI
- 04961333242535
- Brand
- N/A
- Company
- PENTAX OF AMERICA, INC.
- Model
- 92189/12
- Device description
- CBL, ST - LC 62.5/125 4 CT BKT 12
- Published
- 2018-03-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| OUG | Medical Device Data System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04961333242535 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04961333242535 | 04961333242535 | 4961333242535 |
GMDN Terms
| Term | Definition |
|---|---|
| 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). |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Length | 12 | Feet |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 083211284
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 04961333255702 | LARYNGOSTROBOSCOPE | 9500LX | 2025-04-25 | |
| 04961333255719 | LARYNGOSTROBOSCOPE | 9500MC | 2025-04-25 | |
| 04961333255726 | LARYNGOSTROBOSCOPE | 9500FS | 2025-04-25 | |
| 00854924006255 | C2 CryoBalloon Ablation System | FG-1025 | 2025-04-04 | |
| 00854924006293 | C2 CryoBalloon Ablation System | FG-1029 | 2025-04-04 | |
| 04961333255313 | C2 CryoBalloon | FG-1055 | 2024-09-12 | |
| 04961333255320 | C2 CryoBalloon | FG-1056 | 2024-09-12 | |
| 04961333254309 | MULTI-SPEECH | 3706-1 | 2023-08-25 | |
| 04961333248117 | Pentax of America | 9380 | 2022-11-04 | |
| 04961333248445 | C2 CryoBalloon Nitroclip | FG-1050 | 2020-08-07 | |
| 00854924006408 | C2 CryoBalloon EndoGrip | FG-1040 | 2020-07-29 | |
| 04961333248001 | ENDOPRO REVIEW WORKSTATION | KBM68344 | NA | 2020-03-26 |
| 04961333248018 | ENDOPRO NETWORK CAPTURE WORKSTATION | KBM68345 | 2020-03-26 | |
| 04961333248025 | ENDOPRO STANDALONEC CAPTURE WORKSTATION | KBM68346 | 2020-03-26 | |
| 04961333244355 | BRANDMAX | U-5LH | 2018-03-15 | |
| 04961333244188 | N/A | OS-H5 | 2018-03-15 |
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