n.a.
- Primary DI
- 04048551347317
- Brand
- n.a.
- Company
- Karl Storz GmbH & Co. KG
- Model
- 27550C-10
- Device description
- Sealing Cap Ø 1.2 mm, package of 10
- 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
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| FGB | Ureteroscope and accessories, flexible/rigid |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K940464 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04048551347300 | Primary | GS1 | 0 | |
| 04048551347317 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04048551347300 | 04048551347300 | 4048551347300 |
| 04048551347317 | 04048551347317 | 4048551347317 |
GMDN Terms#
| Term | Definition |
|---|---|
| Endoscope working-channel seal | A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 315731430
- Device count
- 10
- 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
- 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#
| 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 |
|---|---|---|---|---|
| 00850023925602 | WiScope® | Otu Medical Inc. | FGB | 2026-07-28 |
| 00850023925619 | WiScope® | Otu Medical Inc. | FGB | 2026-07-28 |
| 00850023925626 | WiScope® | Otu Medical Inc. | FGB | 2026-07-28 |
| 00850023925633 | WiScope® | Otu Medical Inc. | FGB | 2026-07-28 |
| 00850023925640 | WiScope® | Otu Medical Inc. | FGB | 2026-07-28 |
| 00850023925657 | WiScope® | Otu Medical Inc. | FGB | 2026-07-28 |
| 00850023925978 | Aptra | Otu Medical Inc. | FGB | 2026-07-28 |
| 06972084140429 | Aptra | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140436 | Aptra | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140443 | Aptra | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140450 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140467 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140474 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140481 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140535 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140542 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140559 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140566 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140573 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140580 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140702 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140719 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140757 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140764 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140771 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140788 | WiScope® | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140795 | Aptra | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06972084140801 | Aptra | Ningbo Wise Optomech Technology Corporation | FGB | 2026-07-28 |
| 06979988682000 | Single-Use Ureterorenoscope | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FGB | 2026-07-25 |
| 06979988682017 | Single-Use Ureterorenoscope | Shenzhen HugeMed Medical Technical Development Co., Ltd. | FGB | 2026-07-25 |