FDA UDI
In Commercial Distribution
🇺🇸 United States
PTFE coated cannula Ø 10 mm, 330 mm for irrigation/suction system, single use
DI: E296OMSFLA031
·
Model: OMS/FLA03
·
AB MEDICA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- PTFE coated cannula Ø 10 mm, 330 mm for irrigation/suction system, single use
- Primary DI
- E296OMSFLA031
- Version / Model
- OMS/FLA03
- Company Name
- AB MEDICA
- Labeler DUNS
- 260445203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2018-07-23
- Public Version
- 2
- Public Version Date
- 2018-12-10
- Public Version Status
- Update
- Public Device Record Key
- 5815bf9e-b6c1-4a97-a9c1-ce17a96c6b56
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47342 | Laparoscopic irrigation/aspiration cannula | A rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E296OMSFLA031 | HIBCC | ||||
| Unit of Use | E296OMSFLA030 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151822 | 000 |