DeRoyal
- Primary DI
- 50749756835935
- Brand
- DeRoyal
- Company
- DEROYAL INDUSTRIES, INC.
- Model
- 32-2019
- Catalog number
- 32-2019
- Device description
- Custom Polyethylene Tubing
- Published
- 2023-02-02
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| GBX | CATHETER, IRRIGATION |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| GBX | Catheter, Irrigation | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 50749756835935 | Package | GS1 | 20 | In Commercial Distribution |
| 00749756835930 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 50749756835935 | 50749756835935 | ||
| 00749756835930 | 00749756835930 | 749756835930 | 0749756835930 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical irrigation tubing set, single-use | A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 096372255
- 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
- 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 |
|---|---|---|---|---|
| 50749756033140 | DeRoyal | 10-5130 | 10-5130 | 2023-01-31 |
| 50749756392490 | DeRoyal | NP-6006U | NP-6006U | 2026-01-22 |
| 50749756397808 | DeRoyal | NP-0080LMD | NP-0080LMD | 2026-01-22 |
| 00749756401258 | DeRoyal | STM2000 | STM2000 | 2026-01-22 |
| 50749756401352 | DeRoyal | M60-AP500 | M60-AP500 | 2026-01-22 |
| 50749756401376 | DeRoyal | M60-AP600 | M60-AP600 | 2026-01-22 |
| 50749756401383 | DeRoyal | M60-AP601 | M60-AP601 | 2026-01-22 |
| 50749756401390 | DeRoyal | M60-AP602 | M60-AP602 | 2026-01-22 |
| 50749756401482 | DeRoyal | 46-LT19S-01B | 46-LT19S-01B | 2026-01-22 |
| 50749756401437 | DeRoyal | M70-200P | M70-200P | 2026-01-01 |
| 50749756401444 | DeRoyal | M70-200C | M70-200C | 2026-01-01 |
| 50749756401451 | DeRoyal | M70-200CNW | M70-200CNW | 2026-01-01 |
| 50749756401468 | DeRoyal | M70-200PNW | M70-200PNW | 2026-01-01 |
| 50749756394418 | DeRoyal | 71-0805 | 71-0805 | 2025-08-13 |
| 50749756396641 | DeRoyal | PH81-010400 | PH81-010400 | 2025-08-13 |
| 50749756397853 | DeRoyal | PH81-020409 | PH81-020409 | 2025-08-13 |
| 50749756397860 | DeRoyal | PH81-020412 | PH81-020412 | 2025-08-13 |
| 00749756399333 | DeRoyal | 1-524A-01-CHO | 1-524A-01-CHO | 2025-07-30 |
| 00749756399340 | DeRoyal | 1-524A-02-CHO | 1-524A-02-CHO | 2025-07-30 |
| 00749756399357 | DeRoyal | 1-524A-03-CHO | 1-524A-03-CHO | 2025-07-30 |
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