N/A
- Primary DI
- 04961333229697
- Brand
- N/A
- Company
- PENTAX OF AMERICA, INC.
- Model
- 4333
- Device description
- Palatometer Database Program, Software
- Published
- 2017-04-05
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KLX | Electroglottograph |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KLX | Electroglottograph | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04961333229697 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04961333229697 | 04961333229697 | 4961333229697 |
GMDN Terms
| Term | Definition |
|---|
| Electroglottograph | A graphic recorder designed for recording the changes in electrical potential or impedance, using a sensor, resulting from movement of the vocal cords during respiration and phonation. It is intended to be used to asses the degree of closure of the vocal cords during treatment of voice disorders and in the study of the laryngeal mechanism. |
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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 04961333255979 | MICROPHONE ASSAY KIT | PENTAX OF AMERICA, INC. | KLX | 2025-07-21 |
| 04961333255986 | Disposables Kit | PENTAX OF AMERICA, INC. | KLX | 2025-07-21 |
| 00860011116905 | Two Channel Electroglottograph EG2-PCX2 | Glottal Enterprises, Inc. | KLX | 2024-07-01 |
| 04961333254309 | MULTI-SPEECH | PENTAX OF AMERICA, INC. | KLX | 2023-08-25 |
| 04961333247301 | NASOMETER | PENTAX OF AMERICA, INC. | KLX | 2019-06-07 |
| 04961333247318 | NASOMETER | PENTAX OF AMERICA, INC. | KLX | 2019-06-07 |
| 04961333247417 | PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) | PENTAX OF AMERICA, INC. | KLX | 2019-06-07 |
| 04961333247424 | PHONATORY AERODYNAMIC SYSTEM | PENTAX OF AMERICA, INC. | KLX | 2019-06-07 |
| 04961333245390 | VISI-PITCH | PENTAX OF AMERICA, INC. | KLX | 2018-07-05 |
| 04961333245406 | N/A | PENTAX OF AMERICA, INC. | KLX | 2018-07-05 |
| 04961333245413 | NASOMETER II | PENTAX OF AMERICA, INC. | KLX | 2018-07-05 |
| 04961333245420 | PHONATORY AERODYNAMIC SYSTEM | PENTAX OF AMERICA, INC. | KLX | 2018-07-05 |
| 04961333244621 | VISI-PITCH | PENTAX OF AMERICA, INC. | KLX | 2018-03-26 |
| 04961333244638 | NASOMETER II | PENTAX OF AMERICA, INC. | KLX | 2018-03-26 |
| 04961333244645 | PHONATORY AERODYNAMIC SYSTEM | PENTAX OF AMERICA, INC. | KLX | 2018-03-26 |
| 04961333241965 | N/A | PENTAX OF AMERICA, INC. | KLX | 2018-03-06 |
| 04961333240487 | N/A | PENTAX OF AMERICA, INC. | KLX | 2018-02-26 |
| 04961333236558 | NASOMETER II | PENTAX OF AMERICA, INC. | KLX | 2017-11-14 |
| 04961333236565 | PHONATORY AERODYNAMIC SYSTEM | PENTAX OF AMERICA, INC. | KLX | 2017-11-14 |
| 04961333236572 | VISI-PITCH | PENTAX OF AMERICA, INC. | KLX | 2017-11-14 |
| 04961333236589 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-11-14 |
| 04961333236718 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-11-09 |
| 04961333235421 | CAPE V | PENTAX OF AMERICA, INC. | KLX | 2017-09-05 |
| 04961333235438 | VISI-PITCH | PENTAX OF AMERICA, INC. | KLX | 2017-09-05 |
| 04961333235445 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-09-05 |
| 04961333229864 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-04-07 |
| 04961333230020 | MULTI-SPEECH | PENTAX OF AMERICA, INC. | KLX | 2017-04-07 |
| 04961333230037 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-04-07 |
| 04961333230044 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-04-07 |
| 04961333230051 | N/A | PENTAX OF AMERICA, INC. | KLX | 2017-04-07 |