Endosee Cystoscopy Kit
- Primary DI
- 60888937022485
- Brand
- Endosee Cystoscopy Kit
- Company
- Coopersurgical, Inc.
- Model
- OR-ESCX10KIT
- Device description
- Cystoscopy kit, flexible cystoscopy cannula and sterile drape, 10 of each
- Published
- 2018-11-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K170660 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 60888937022485 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 60888937022485 | 60888937022485 |
GMDN Terms#
| Term | Definition |
|---|---|
| Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 801895244
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00888937027327 | ER-Spec | C020300 | 2026-08-05 | |
| 00888937027334 | ER-Spec | C020310 | 2026-08-05 | |
| 00888937027341 | ER-Spec | C020320 | 2026-08-05 | |
| 00888937027358 | HER-Spec | C020600 | 2026-08-05 | |
| 00888937027365 | HER-Spec | C020610 | 2026-08-05 | |
| 00888937027372 | HER-Spec | C020620 | 2026-08-05 | |
| 00888937027389 | OfficeSPEC | C020001 | 2026-08-06 | |
| 00888937027396 | HER-Spec | C020500 | 2026-08-06 | |
| 00888937027402 | HER-Spec | C020510 | 2026-08-06 | |
| 00888937027419 | HER-Spec | C020520 | 2026-08-06 | |
| 00888937027426 | ER-SPEC | C020100-1 | 2026-08-06 | |
| 00888937027433 | ER-SPEC | C020110-1 | 2026-08-06 | |
| 00888937027440 | ER-Spec | C020120-1 | 2026-08-06 | |
| 00888937027457 | ER-Spec | C020130-1 | 2026-08-06 | |
| 00888937027464 | ER-Spec | C020140-1 | 2026-08-06 | |
| 00888937027594 | AnoSPEC | C060100 | 2026-08-05 | |
| 00888937027600 | AnoSPEC | C060110 | 2026-08-05 | |
| 00888937027617 | AnoSPEC | C060120 | 2026-08-05 | |
| 00888937032833 | LifeGlobal® Coda® | Incubator Unit | GCIU-010-M | 2026-08-03 |
| 00888937032840 | LifeGlobal® Coda® | Filter for Incubator Unit | GCIF-001-M | 2026-08-03 |
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|---|---|---|---|---|
| 04580826926952 | PENTAX Medical | PENTAX MEDICAL CORPORATION | FAJ | 2026-08-25 |
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| 00197998305016 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305030 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305078 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
| 00197998305092 | Solventum™ Steri-Drape™ | Solventum US LLC | PUI | 2026-08-23 |
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