n.a.
- Primary DI
- 04048551417355
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 091370-06
- Device description
- CMOS Video Esophagoscope SSU
- Published
- 2020-03-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| EOX | Esophagoscope (flexible or rigid) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | Ear, Nose, Throat | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K192523 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551417348 | Primary | GS1 | 0 | |
| 04048551417355 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551417348 | 04048551417348 | 4048551417348 |
| 04048551417355 | 04048551417355 | 4048551417355 |
GMDN Terms#
| Term | Definition |
|---|---|
| Flexible video oesophagoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 315731430
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04048551001141 | n.a. | 495NCS | 2016-09-23 | |
| 04048551004401 | n.a. | 495TIP | 2016-09-23 | |
| 04048551004463 | n.a. | 50200FFL | 2018-08-21 | |
| 04048551028568 | n.a. | 495ADM | 2016-09-23 | |
| 04048551049549 | n.a. | 10970AE | 2018-08-17 | |
| 04048551049563 | n.a. | 10970BE | 2018-08-17 | |
| 04048551052495 | n.a. | 12016EM | 2016-09-23 | |
| 04048551052525 | n.a. | 12016FM | 2016-09-23 | |
| 04048551052990 | n.a. | 12061A | 2016-09-23 | |
| 04048551053003 | n.a. | 12061AU | 2016-09-23 | |
| 04048551053010 | n.a. | 12061AV | 2016-09-23 | |
| 04048551053027 | n.a. | 12061AW | 2016-09-23 | |
| 04048551053034 | n.a. | 12061AX | 2016-09-23 | |
| 04048551053041 | n.a. | 12061B | 2016-09-23 | |
| 04048551053065 | n.a. | 12061C | 2016-09-23 | |
| 04048551053072 | n.a. | 12061F | 2016-09-23 | |
| 04048551053089 | n.a. | 12061G | 2016-09-23 | |
| 04048551053096 | n.a. | 12061H | 2016-09-23 | |
| 04048551053102 | n.a. | 12061K | 2016-09-23 | |
| 04048551082027 | n.a. | 233250B | 2016-09-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04961333251766 | PENTAX Medical | HOYA CORPORATION | EOX | 2023-06-21 |
| 00860008795557 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics Inc | EOX | 2023-01-26 |
| 04048551417348 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2020-03-02 |
| 00860002356006 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics Inc | EOX | 2019-12-17 |
| 00874485003210 | UNITY 9100 | COGENTIX MEDICAL, INC. | EOX | 2018-12-20 |
| 04048551178515 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551178539 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551178546 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551190098 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551190104 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 04048551190111 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2018-07-21 |
| 00874485002985 | EndoSheath Technology | COGENTIX MEDICAL, INC. | EOX | 2016-09-23 |
| 00874485003005 | EndoSheath Technology | COGENTIX MEDICAL, INC. | EOX | 2016-09-23 |
| 04048551001387 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551001493 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551001974 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047675 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047811 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047828 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047866 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047873 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047897 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047903 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047941 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047989 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551047996 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551048641 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551048658 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551053591 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |
| 04048551068762 | n.a. | Karl Storz GmbH & Co. KG | EOX | 2016-09-23 |