ROEKO Surgitip
- Primary DI
- E1654620260
- Brand
- ROEKO Surgitip
- Company
- Coltène/Whaledent GmbH + Co. KG
- Model
- 462026
- Catalog number
- 462026
- Published
- 2016-08-23
- Public version status
- Update
- 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 |
|---|
| JOL | Catheter And Tip, Suction |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JOL | Catheter And Tip, Suction | General Hospital | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| E1654620260 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Outer Diameter | 6.5 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | keep away from sunlight |
| Special Storage Condition, Specify | 0 | 0 | keep dry |
| Storage Environment Temperature | 2 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 37 Degrees Fahrenheit | 77 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 315494443
- 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 |
|---|
| E165H021220 | HYGENIC® Paper Points | H03180 | H03180 | 2023-02-13 |
| E165H021230 | HYGENIC® Paper Points | H02123 | H02123 | 2023-02-13 |
| E165H021240 | HYGENIC® Paper Points | H02124 | H02124 | 2023-02-13 |
| E165H021300 | HYGENIC® Paper Points | H02130 | H02130 | 2023-02-13 |
| E165H021310 | HYGENIC® Paper Points | H02131 | H02131 | 2023-02-13 |
| E165H031870 | HYGENIC® Paper Points | H03187 | H03187 | 2023-02-13 |
| E165H031880 | HYGENIC® Paper Points | H03188 | H03188 | 2023-02-13 |
| E165H031890 | HYGENIC® Paper Points | H03189 | H03189 | 2023-02-13 |
| E165H031900 | HYGENIC® Paper Points | H03190 | H03190 | 2023-02-13 |
| E165H031910 | HYGENIC® Paper Points | H03191 | H03191 | 2023-02-13 |
| E165H031980 | HYGENIC® Paper Points | H03198 | H03198 | 2023-02-13 |
| E165H076770 | HYGENIC® Paper Points | H07677 | H07677 | 2023-02-13 |
| E165H076780 | HYGENIC® Paper Points | H07678 | H07678 | 2023-02-13 |
| E165H076790 | HYGENIC® Paper Points | H07679 | H07679 | 2023-02-13 |
| E165H076800 | HYGENIC® Paper Points | H07680 | H07680 | 2023-02-13 |
| E165H076810 | HYGENIC® Paper Points | H07681 | H07681 | 2023-02-13 |
| E165H076820 | HYGENIC® Paper Points | H07682 | H07682 | 2023-02-13 |
| E165H076830 | HYGENIC® Paper Points | H07683 | H07683 | 2023-02-13 |
| E165H076840 | HYGENIC® Paper Points | H07684 | H07684 | 2023-02-13 |
| E165H076850 | HYGENIC® Paper Points | H07685 | H07685 | 2023-02-13 |
Other Devices Sharing Product Codes
coltene.com