FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04961333245246
·
Model: OS-A17
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 04961333245246
- Version / Model
- OS-A17
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-16
- Public Version
- 4
- Public Version Date
- 2020-05-19
- Public Version Status
- Update
- Public Device Record Key
- 8602c766-b8b8-4e8a-8a2c-1d83d653c322
Device Description
CBL,BNC-BNC,6, EPK-3000
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
- No
- 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 |
|---|---|---|---|---|
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18034 | Endoscopic video image processing unit | An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333245246 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172156 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.0 | Feet |