MicroFrance®
- Primary DI
- 10381780090649
- Company
- INTEGRA MICROFRANCE
- Model
- 7881
- Device description
- TUBE 7881 FOR PROETZ
- Published
- 2017-06-02
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Regulatory Flags
- DUNS number
- 276593071
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780090649 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 10381780090649 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| KAR | Irrigator, Sinus | 1 | Ear, Nose, Throat | 874.4420 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|---|
| Surgical/emergency suction cannula, non-illuminating, reusable | An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780093558 | Integra® MicroFrance® | CEV504A | 2016-09-21 | |
| 10381780093565 | Integra® MicroFrance® | CEV504B | 2016-09-21 | |
| 10381780259367 | MicroFrance® | CEV405U | CEV405U | 2019-02-20 |
| 10381780259435 | MicroFrance® | CEV531T3U | CEV531T3U | 2019-02-20 |
| 10381780259503 | MicroFrance® | CEV649B5U | CEV649B5U | 2019-02-20 |
| 10381780259510 | MicroFrance® | CEV649BGPU | CEV649BGPU | 2019-02-20 |
| 10381780259572 | MicroFrance® | CEV728BR5U | CEV728BR5U | 2019-02-20 |
| 10381780259619 | MicroFrance® | CEV8649B5U | CEV8649B5U | 2019-02-20 |
| 10381780259626 | MicroFrance® | CEV8649BGPU | CEV8649BGPU | 2019-02-20 |
| 10381780259664 | MicroFrance® | CEV891MU | CEV891MU | 2019-02-20 |
| 10381780259695 | MicroFrance® | CEV894MU | CEV894MU | 2019-02-20 |
| 10381780259718 | MicroFrance® | CEV895MU | CEV895MU | 2019-02-20 |
| 10381780259794 | MicroFrance® | CEV9649B5U | CEV9649B5U | 2019-02-20 |
| 10381780259800 | MicroFrance® | CEV9649BGPU | CEV9649BGPU | 2019-02-20 |
| 10381780259879 | MicroFrance® | CM107U | CM107U | 2019-02-20 |
| 10381780259886 | MicroFrance® | CM110U | CM110U | 2019-02-20 |
| 10381780259893 | MicroFrance® | CM111U | CM111U | 2019-02-20 |
| 10381780259909 | MicroFrance® | CM112U | CM112U | 2019-02-20 |
| 10381780259916 | MicroFrance® | CM113U | CM113U | 2019-02-20 |
| 10381780259923 | MicroFrance® | CM115U | CM115U | 2019-02-20 |